Open Protocols

ANBL0032: Phase III Randomized Study of Chimeric Anti-GD2 in High Risk
Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

Physician Summary: < age 30; High Risk: Anti-GD2 Following ASCR

COG-ANBL0532: Phase III Randomized Trial of Single vs. Tandem Myeloablative as Consolidation Therapy for High-Risk Neuroblastoma

Physician Summary: ≤ age 30: Single vs. Tandem Myeloblative as Consolidation Therapy

COG-ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Physician Summary: > Age 21; Newly Dx: RT+ Vincristine +/- Carboplatin f/b Maint +/- Continuous Isotretinoin

N0577: Phase III Intergroup Study of Radiotherapy versus Temozolomide alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma

Physician Summary: > Age 18; Staging: Co-deleted 1p/19q Anaplastic Glioma; Treatment: RT vs Temozolomide alone vs RT with concomitant & Adjuvant Temozolomide.

NCCTG N057K: Phase I/II Evaluation of Everolimus (RAD001), Radiation and Temozolomide (TMZ) Followed by Adjuvant Temozolomide and Everolimus in Newly Diagnosed Glioblastoma

Physician Summary:  > Age 18; Grade IV Astrocytoma (GBM); Treatment: Everolimus + RT + Temozolomide f/b Everolimus + Temozolomide f/b Everolimus

70305: A Randomized Study to Prevent Lymphedema in Women Treated For Breast Cancer

Physician Summary: Newly Diagnosed Stage I – IV: Study to Prevent Lymphedema

369901: Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older with Operable, Newly Diagnosed Breast Cancer

Physician Summary: Chemotherapy Decisions/Outcomes in Women > 65 with Operable/Newly Diagnosed

70301: Quality Of Life, Employment And Informal Care Cost Analysis In Women Receiving  Adjuvant Chemotherapy For Breast Cancer With 0-3 Positive Axillary Lymph Nodes

Physician Summary: QOL, Employment, & Informal Care Cost Analysis Pts. Receiving Adjuvant Chemotherapy

SWOG S0715 - Randomized Placebo-Controlled Trial of Acetyl L-Carnitine for the Prevention of Taxane Induced Neuropathy

Physician Summary: > Age 18; Stage I, II, IIIa Breast Cancer: Treatment: ALC or Placebo

NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

Physician Summary: ≥ age 18, Central HER2 Testing: RT +/- Trastuzumab

Closing on 8/20/10! PACCT-1: Program for the Assessment of Clinical Cancer Tests: Trial Assigning Individualized Options for Treatment; The TAILORx Trial

Physician Summary: Tailorx: T1b-T3: Accessing Risk Using Oncotype Testing; Mid-risk Random. to Hormonal Tx vs Chemo

E5103: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer

Physician Summary: ≥ age 18, HER2 (-): AC + Bevacizumab/Placebo f/b Taxol + Bevacizumab/Placebo

(St. Mary's & MMC Only)  B-39: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

Physician Summary: <age 50 if stage 0; >age 50 for Stage I & II if Node+ and/or ER-/PR-: Conventional Whole Breast Irradiation (WBI) vs. Partial Breast Irradiation (PBI)

SCRI BRE 145: A Randomized Trial of IxempraTM vs. Taxol in Adjuvant Therapy of Triple-Negative Breast Cancer (TITAN)

Physician Summary: ≥ age 18; pN1mi-pN2b or T1c-T3: AC f/b Ixabepilone vs AC f/b Paclitaxel

NSABP B-44-I, the BETH Trial: A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy PlusTrastuzumab Plus Bevacizumab

Physician Summary: ≥ age 18, Stage I if High Risk, IIA, IIB, IIIA and IIIC for T≤3: Docetaxel + Carboplatin + Trastuzumab +/- Bevacizumab

S0221: Phase III Trial of Continuous Schedule AC + G Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

Physician Summary: Stage I-III; No prior tx:: AC+ PEG-Gq 2 wks x6 or AC + GCSF wkly x15 f/b PEG-Gq 2 wks x6 or T weekly x12

CTSU Z1071: A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis

Physician Summary:

SCRI BRE 139: Phase II Study of Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer

Physician Summary: ≥ age 18; Stage T1-T3, N0-N2, HER2(+): Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab fb surgery fb Adjuvant Trastuzumab

NSABP FB-6 - A Phase II Clinical Trial of Four Cycles of Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Given Concurrently with Pazopanib as Neoadjuvant Therapy Followed by Postoperative Pazopanib for Women with

Physician Summary: ≥ age 18; Staging IIIA,B,C: Doxorubicin/Cyclophosphamide f/b Concurrent Paclitaxel/Pazopanib
f/b Post-Operative Pazopanib

40502: A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanopartical Albumin Bound Nab-Paclitaxel or Ixabepilone Combined with Bevacizumab as First -Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Physician Summary: ≥ age 18, Stage IIIB or IV,: Paclitaxel or Nab-Paclitaxel or Ixabepilone w/Bevacizumab

S0500: A Randomized Phase III Trial to Test the Strategy of Changing Therapy Vs. Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment

Physician Summary: Any T, Any N, M1; Doctor Decides Chemo Tx /> Circ. Tumor Cells (High Risk) May Be Randomized to Switch Chemo @ first f/u Assessment. Hormonal and Bio Txs Continued Unchanged

70305: A Randomized Study to Prevent Lymphedema in Women Treated For Breast Cancer

Physician Summary: Newly Diagnosed Stage I – IV: Study to Prevent Lymphedema

GOG 0256: A PROSPECTIVE STUDY OF COGNITIVE FUNCTION DURING CHEMOTHERAPY FOR FRONT-LINE TREATMENT IN OVARIAN, PRIMARY PERITONEAL OR FALLOPIAN TUBE CANCER

Physician Summary:

369901: Observational Cohort Study: Chemotherapy Decisions and Outcomes in Women Age 65 or Older with Operable, Newly Diagnosed Breast Cancer

Physician Summary: Chemotherapy Decisions/Outcomes in Women > 65 with Operable/Newly Diagnosed

70301: Quality Of Life, Employment And Informal Care Cost Analysis In Women Receiving  Adjuvant Chemotherapy For Breast Cancer With 0-3 Positive Axillary Lymph Nodes

Physician Summary: QOL, Employment, & Informal Care Cost Analysis Pts. Receiving Adjuvant Chemotherapy

SWOG S0715 - Randomized Placebo-Controlled Trial of Acetyl L-Carnitine for the Prevention of Taxane Induced Neuropathy

Physician Summary: > Age 18; Stage I, II, IIIa Breast Cancer: Treatment: ALC or Placebo

NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

Physician Summary: ≥ age 18, Central HER2 Testing: RT +/- Trastuzumab

MD Anderson 2006-0198: CAM Use and Cancer

Physician Summary: Nursing Study Only - Check with GRCOP at 616.391.1230

Open to Minorities Only   N08C7: A Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes

Physician Summary:

N08C1: Paclitaxel-Associated Acute Pain Syndrome Natural History Study

Please Note: Arm B Closed; Arm C may accrue minority patients only!

Physician Summary: ≥ age 18; Any Staging: Standard of Care with Use of Paclitaxel

RC08C6: White Wine for Appetite Loss: A Randomized, Controlled Non-blinded Trial

Physician Summary:

Closing August 31, 2010.  URCC 07004: Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy (ATTRACT-CPN)

Physician Summary: ≥ age 18; Post Chemo; Symptoms Persisting ≥28 days: Amitriptyline/Ketamine Cream vs Placebo

N07C2: The Use of Wisconsin Ginseng (Panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

Physician Summary: ≥ age 18, Tx must be curative: Wisconsin Ginseng

2004-0024: Chemotherapy and Mindfulness Relaxation: A Randomized Trial At M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program

Physician Summary: Chemotherapy & Mindfulness Relaxation/Randomized Trial

SWOG S0702: A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients With Bone Metastasis Starting Zoledronic Acid Treatment

Physician Summary: ≥ age 18; Bone Mets: Assess ONJ in Patients receiving Zometa

Closed to Accrual!  SELECT.  For documents related to the transitional phase of this study, go the the GRCOP Members Site.

Physician Summary:

RTOG 0436: A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Physician Summary: > Age 18; T1N1M0; T2-4, Any N, M0; Any T, and N, M1a.  Treatment: Concurrent Radiation with Paclitaxel and Cisplatin, w/ or w/o Cetuximab

Phase II Portion Closed! NCCTG N0745: Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma

Physician Summary: ≥ age 18; Locally Advanced or Mets, Not Amenable to Surgery: Phase I Dose Finding Tx = Sorafenib + Bevacizumab

Closing on 8/6/10!  N064A: Phase II Study of Panitumumab, Chemotherapy and External Beam Radiation in Patients with Locally Advanced Pancreatic Cancer

Physician Summary: ≥ age 18; Locally Adv, nonresectable: Panitumumab + 5-FU (or Capcitabine) + RT f/b Panitumumab + Gemcitabine f/b maint. Panitumumab

SWOG S0727: A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First-Line Treatment in Patients with Metastatic Pancreatic Cancer

Physician Summary: ≥ age 18; Any T, Any N, M1 (Distant mets): Gemcitabine + Erlotinib + IMC-A12 vs Gemcitabine + Erlotinib

Closing 8/16/10!  R-04: A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Flourouracil with or without Oxaliplatin in t

Physician Summary: Neoadjuvant; Stage II/III; complete colonoscopic exam required: CI 5FU + XRT +/- Oxaliplatin vs Capecitabine + XRT +/- Oxaliplatin

E5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin vs. 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognost

Physician Summary: Stage II; 5-FU, Leucovorin + Oxaliplatin vs. 5-FU, Leucovorin, Oxaliplatin + Bevacizumab

CALGB 80405: (Arm C Closed) A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with evacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab For Patients with Untreated Metastati

Physician Summary: Locally Advanced or Untreated Mets; Unresectable; Wild K-Ras Gene Only: Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab  (Ancillary 150506 & 60501 Suggested)

Closed to Accrual!  SELECT.  For documents related to the transitional phase of this study, go the the GRCOP Members Site.

Physician Summary:

CALGB 90203: Randomized Phase III Study Of Neo-Adjuvant Docetaxel And Androgen Deprivation Prior To Radical Prostatectomy Versus Immediate Radical Prostatectomy In Patients With High-Risk, Clinically Localized Prostate Cancer

Physician Summary: ≥ Age 18: LHRH + Docetaxel f/b Radical Prosatectomy w/staging PLND vs Radical Prostatectomy w/staging PLND

AREN0532: Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms Tumor

Physician Summary: < age 30; Newly Diagnosed; Stages I&II: Observation vs EE4A vs DD4A; Stage III: DD4A + XRT or Offer AREN0533

AREN0533: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Physician Summary: < age 30, Newly Dx Higher Risk: VCR, AMD, DOXO per DD4A for 2 cycles + DD4A vs Regimen M

AREN0321: Treatment of High Risk Renal Tumors

Physician Summary: ≤ age 30, Newly Diagnosed Stage I-IV, Chemo –vs- Surgery Only (Ancillary AREN03B2 Required)

E2805: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Physician Summary: ≥ T1b, N any, M0: Double Blind Study/Sunitinib vs. Sorafenib vs. Placebo

E2804: The BeST Trial: A Randomized Phase II Study of VEGF, RAF kinase, and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma

Physician Summary: ≥ age 18: Bevacizumab vs Bevacizumab+Tersirolimus vs Bevacizumab +Sorafenib vs Sorafenib+

GU56: A Phase II Trial of Pazopanib in Patients with Metastatic Renal Cell Carcinoma Previously Treated with Sunitinib or Bevacizumab

Physician Summary: ≥ age 18; Unresectable Locally Recurrent or Metastatic w/Failed Prior Chemo: Oral Pazopanib

GOG 0256: A PROSPECTIVE STUDY OF COGNITIVE FUNCTION DURING CHEMOTHERAPY FOR FRONT-LINE TREATMENT IN OVARIAN, PRIMARY PERITONEAL OR FALLOPIAN TUBE CANCER

Physician Summary:

GOG 0212: A Randomized Phase III Trial Of Maintenance Chemotherapy Comparing 12, Monthly Cycles Of Single Agent Paclitaxel Or Xyotax? (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse In Women With Advanced Ovarian Or Primary Peritoneal Cancer Who Achieve A Complete Clinical Respo

Physician Summary: Paclitaxel or Xyotax™ vs. No Treatment Until Documented Relapse

SCRI GYN 19: A Randomized Phase II Study of Paclitaxel/Carboplatin with or without Sorafenib in the First –Line Treatment of Patients with Stage III/IV Epithilial Ovarian Cancer

Physician Summary: ≥ age 18; Stage III/IV; Paclitaxel/Carboplatin with or without Sorafinib

GOG 0213: A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC #704865, IND #7921) Followed By Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal

Physician Summary: ≥ age 18; Recurrent: If surgery candidate, Randomize to +/- Surgery; For all Patients: Carboplatin/Taxol vs. Carboplatin/Taxol +/- Bevacuzimab

GOG 0252: A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: NCI-Supplied Agent: Bevacizumab (NSC #704865, IND #7921)

Physician Summary: > Age 18; Stage II, Stage III if no measurable and residual disease > 1cm after surgery: Add Bevacizumab to all 3 of the following regimens IV Carboplatin vs IP Carboplatin vs IP Cisplatin

0248: A Randomized Phase II Trial of Temsirolimus or the Combination of Hormonal Therapy Plus Temsirolimus in Women With Advanced, Persistent, or Recurrent Endometrial Carcinoma (Arm 2 closed)

Physician Summary: Stage III or IV; Persistent or Recurrent Endometrial: Temsirolimus vs Megestrol Acetate/Tamoxifen + Temsirolimus  (Arm 2 Closed)

GOG 0258: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel VS. Carboplatin and Palitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Physician Summary: ≥ age 18; Debulked Stage III or IVA: Cisplatin/XRT f/b Carboplatin/Paclitaxel vs Carboplatin/Palitaxel

E1305: A Phase III Randomized Trial of Chemotherapy with or without
Bevacizumab In Patients with Recurrent Or Metastatic Head and Neck Cancer

Physician Summary: ≥ age 18; No Prior Chemo for Recurr or Mets: Cisplatin-doublet (phys. Choice) +/- Bevacizumab

SWOG S0805: Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) with or without Allogeneic Stem Cell Transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (a BMT Study)

Physician Summary: > Age 18 and < Age 50; Philadelphia or Oncogene Bcr-Abl Positive.  Treatment: Hyper-CVAD/Dasatinib w/ High Dose MTX and Cytarabine/Dasatinib f/b Maintenence Vincristine/Pred/Dasatinib

8461: Cytogenetic Studies In Acute Leukemia

Physician Summary: Previously Untreated AML, ALL, MDS: Bone Marrow and Blood Samples (Ancillary CALGB 9665 Required)

SWOG S9910: “Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary”. (Ancillary study to S0535 and S0703)

Physician Summary: Ancillary study for S0535 & S0703

SWOG 9007: Cytogenetic Studies in Leukemia Patients, Ancillary (Ancillary study to S0535 & S0703)

Physician Summary:

Required Ancillary study to S0535 & S0703

AALL03B1: Classification of Acute Lymphoblastic Leukemia

Physician Summary: ALL/Mandatory Biology Classification Companion to AALL0232

AALL0232: High Risk B-Precursor Acute Lymphoblastic Leukemia

Physician Summary: < 30 years of age, High Risk B-precursor (Pre-requisite = Ancillary AALL03B1)

AALL0434: Intensified Methotrexate, Nelarabine (Compound 506U78; IND#52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL)

Physician Summary: Age 0-30; Newly Diag. T-Cell ALL; Methotrexate, Nelarabine and Augmented BFM Therapy (Prerequisite AALL03B1)

AALL0433: Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies

Physician Summary:   ≤ age 30; Initial Intermed-Risk Relapse of B-precursor: Standard VCR Dosing vs Intensive VCR Dosing

ADVL04P2: A Feasibility Pilot and Phase 2 Study of Chemoimmunotherapy with Epratuzumab for Children with Relapsed CD22-Positive Acute Lymphoblastic Leukemia

Physician Summary: < age 31; Relapsed B-Precurser: Reinduction Chemo + Epratuzumab

AALL02P2: Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblstic Leukemia (ALL) (Initial CR1>/=18 months)

Physician Summary: < 30 years of Age, Late Isolated Extramedullary Relapse, (Pre-requisite = Ancillary AALL03B1)

AALL07P1:  A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

Physician Summary: Relapsed B-precursor ALL, relapsed T-cell ALL and relapsed T-LL: Bortezomib w/Intensive Re-Induction Therapy

COG-AAML07P1: A Phase II Pilot Study of Bortezomib (PS-341, Velcade, IND #58,443) Combined with Reinduction Chemotherapy in Children and Young Adults with Recurrent, Refractory or Secondary Acute Myeloid Leukemia

Physician Summary: ≤ age 21; Recurrent, Refractory or Secondary AML: Bortezomib Combined w/ Reinduction Chemotherapy

(Except St. Mary's)  CALGB 10603: A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/ Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age with FLT3 Mutated Acute My

Physician Summary: (Except St. Mary’s)   ≥ age 18 and <60, FLT3 mutation req’d: Ara-C + Daunomycin + Midostaurin/Placebo

TEMP. CLOSED SWOG S0703: A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia

Physician Summary: ≥ age 60; Untreated Non-M3: Azacitidine + Gemtuzumab Ozogamicin as induction & Post-Remission Therapy

AAML0531: A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg®) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

Physician Summary: <30 years; DeNovo Acute AML: Gemtuzumab Ozogamicin (Mylotarg®) + Conventional Chemo

TEMP. CLOSED SWOG S0535: A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

Physician Summary: >18: ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin

MCCRC RC0783: Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin® for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)

Physician Summary: ≥ age 18; Previous Untreated CLL: Pentostatin, Cyclophosphamide, Rituximab with or w/o Avastin

SWOG S0635: A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features (AdenoBAC)

Physician Summary: ≥ age 18; History of Smoking; Stage IIIB or IV: OSI-774 + Bevacizumab

S0720: Phase II ERCC1 And RRM1-Based Adjuvant Therapy Trial In Patients With Stage I Non-Small Cell Lung Cancer (NSCLS)

Physician Summary: ≥ age 18; Stage 1A (w/ tumors > 2 cm) or Stage 1B: Genetic Testing for Risk.  Low Risk = Observation only. High Risk = Cisplatin/Gemcitabine

LUN 144: Phase II Trial Of Preoperative Chemotherapy And Bevacizumab In Patients With Stage IB (>4 CM), II, Or Select Stage III Non-Small Cell Lung Cancer

Physician Summary:

> Age 18; Stage IB, II or Select Stage III: Neoadjuvant Paclitaxel, Carboplatin and Bevacizumab

SWOG S0636: A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas

Physician Summary: ≥ age 18; Non-Smoker; Stage IIIB or IV: OSI-774 + Bevacizumab

(Saint Mary's Health Care Only)  RTOG 0813 - Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients 

Physician Summary: > Age 18; NSCLC Stage T1-2, N0, M0; Treatment: SBRT (Stereotactic Lung Radiotherapy)

CTSU E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4cm) – IIIA Non-Small Cell Lung Cancer (NSCLS)

Physician Summary: ≥ age 18; Stage IB to IIIA: Cisplatin w/choice of Vinorelbine, Taxotere or Gemcitabine +/- Bevacizumab

(St. Mary's Only)  0617: A Randomized Phase IIII Comparison Of Standard- Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent And Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) I

Physician Summary: ≥ age 18, Newly Dx, unresectable Stage IIIA/IIIB: Standard vs High-dose conformal RT with Concurrent and Consolidation Carboplatin/Paclitaxel

SWOG S0709: A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/ Paclitaxel/Erlotinib or Erlotinib Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performance Status 2 (PS 2) Selected by Serum Pr

Physician Summary: ≥ age 18; Proteomic (+); ECOG PS=2; Stage IIIB-IV; 1st Line Chemo: Carboplatin/Paclitaxel/OSI-774 vs OSI-774 alone

SWOG S0819 - A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Physician Summary: > Age 18; Stage IV; Tx: Paclitaxel + Carboplatin + Bevacizumab (if appropriate) +/- Cetuximab

SWOG S0802: A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)

Physician Summary: E-SCLC/ > age 18; Extensive Stage, 2nd line SCLC: Topotecan +/- AVE0005

SWOG 8947: Central Lymphoma Serum Repository Protocol (Ancillary to S0801)

Physician Summary: Suggested Ancillary study to S0801

COG- AHOD0831 A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children with Newly Diagnosed High Risk Hodgkin Lymphoma

Physician Summary: < Age 21; Stage III/IV w/ B Symptoms; Newly Diagnosed: See Fast Facts for Tx Schema. Call Pediatric Nurses at 616.391.1230 with questions.

N078D:  Phase I/II Trial of Rituximab, Cladribine, and Temsirolimus (RCT) Therapy in Newly Diagnosed Mantle Cell Lymphoma (MCL)

Physician Summary:  >  Age 18; Staging: Histologically Confirmed MCL; Treatment: Rituximab, Cladribine and Temsirolimus

SWOG S0816 - A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Early Interim FDG-PET Imaging

Physician Summary: Age 18-60; Stage III/IV: ABVD x2 Cycles f/b PET f/b ABVD x4 or BEACOPP x6

CALGB 50501: A Phase II Trial of Bortezomib + Lenalidomide For Relapsed/ Refractory Mantle Cell Lymphoma (Not available at Saint Mary's Health Care & Mercy Health Partners)

Physician Summary: ≥ age 18; Recurrent or Refractory: Induction Bortezomib & Lenalidomide

SWOG S0801, A Phase II Study of Iodine-131-Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Follicular Non-Hodgkin’s Lymphoma

Physician Summary: ≥ age 18; Advanced Stage Follicular: R-CHOP with Iodine-131 Labeled-Tositumomab f/b Maintenance Rituximab

AALL07P1:  A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

Physician Summary: Relapsed B-precursor ALL, relapsed T-cell ALL and relapsed T-LL: Bortezomib w/Intensive Re-Induction Therapy

MEL 19:  A Phase II Study of Everolimus in Combination with Paclitaxel and Carboplatin in Patients with Metastatic Melanoma

Physician Summary:

> Age 18; Stage III or IV; No prior Cytotoxic or Biologic TX; Prior Immunotherapy allowed. Treatment: Paclitaxel and Carboplatin w/ Oral Everolimus

Temp Closed!   S0826: A Phase II Study of SCH 727965 in Stage IV Melanoma

Physician Summary: ≥ age 18; Stage IV: SCH 727965

SWOG S0777: A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previous

Physician Summary:  ≥ age 18, Untreated MM w/o intent for immediate autologous BMT: Lenalidomide + low-dose Dexamethasone +/- Bortezomib f/b Lenalidomide + low-dose Dexamethasone

AEWS0331: European Ewing Tumor Working Initiative of National Groups Ewing Tumor Studies 1999 (EURO-E.W.I.N.G.99)

Physician Summary: < 50 yr of age; Isolated Pulmonary or Pleural Mets

ARST0332: Risk-Based Treatment for Pediatric Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)

Physician Summary: < age 30, Surgery vs Surgery + XRT vs Surgery + Chemo + XRT/Surgery vs Chemo + XRT + Surgery + Chemo + XRT/Surgery (Chemo = Ifosfomide + Doxirubicin)

ARST0331: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

Physician Summary: Newly Dx, < 50 years old: VAC +/- XRT

ARST0531: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS).

Physician Summary: < age 50; Newly Diagnosed: VAC vs VAC alternating w/ VI; Includes XRT

AOST0331: A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-Operative Chemotherapy

Physician Summary: ≤ age 40; High Grade Osteosarcoma: Resectable/Histological Response to Pre-Operative Chemotherapy

AOST06P1: Feasibility and Dose Discovery Analysis of Zoledronic Acid with Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma

Physician Summary: ≤ age 40; No Prior Chemo; Feasibility & Dose Discovery Analysis of Zoledronic Acid with Concurrent Chemo

N0871: A Phase II Study of Carboplatin (CBDCA), Paclitaxel (TAXOL), and Everolimus (RAD001) in previously Untreated Patients with Measurable Disease with Cancer of Unknown Primary (CUP)

Physician Summary:

UNKPRI 20: A Phase II Study of Chemotherapy Based Treatment on Molecular Profiling Diagnosis for Patients with Carcinoma of Unknown Primary Site

Physician Summary: ≥ age 18; Stage IV Mets; Tx Determined by Results of Gene Assay (Drug Source Depends on Arm)