Microsoft word - north shore cancer research association study list
North Shore Cancer Research Association Study List Edward Kaplan, MD 9631 Gross Point Rd. Suite 10 847.675.3900 (phone) Marlon Kleinman, MD Skokie, IL 60076 847.675.3930 (fax) SponsorProtocol #Study Title
A Phase II Study of Systemic High-Dose Methotrexate for the
Treatment of Glioblastoma Multiforme in Newly Diagnosed
A Phase III (Phase I Closed) Randomized Study of Radiation
Therapy and Temozolomide (IND# 60, 265) versus Radiation
Therapy and BCNU for Anaplastic Astrocytoma and Mixed
Anaplastic Oligoastrocytoma (Astrocytoma Dominant)
Adjuvant SponsorProtocol #Study Title
Cyclophosphamide and Doxorubicin (CA) (4 vs 6 cycles) Versus
Paclitaxel (12 weeks vs 18 weeks) as Adjuvant Therapy for
Women with Node-Negative Breast Cancer A 2x2 Factorial Phase
A Randomized Trial of Adjuvant Chemotherapy with Standard
Regimens, Cyclophosphamide, Methotrexate and Fluorouracil or
Doxorubicin and Cyclophosphamide vs. Capecitabine in Women
65 yrs & Older with Node Positive or High-Risk Node Negative
A Clinical Trial Comparing Anastrozole or Tamoxifen in
Postmenopausal Patients with Ductal Carcinoma in SITU (DCIS)
Undergoing Lumpectomy with Radiation Therapy
Wednesday, October 26, 2005 Page 1 of 10
Phase III Trial of Continuous Schedule AC + G Vs. 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
METASTATIC SponsorProtocol #Study Title
A Phase II Trial of Capecitabine in Combination with the
Farnesyltransferase Inhibitor, R115777 (Tipifarnib, Zarnestra) in
A Phase II Trial of Trastuzumab Plus Weekly Ixabepilone
(BMS-247550) and Carboplatin in Patients with HER2/Neu-
An Open-label Randomized Phase II Study of Two Different
Dosing Regimens of Capecitabine in Combination with
Intravenous Docetaxel (Q3W) In Patients with Locally Advanced
3066A1-303-WW Phase 3 Randomized, Placebo-controlled, Double-Blind Study of
Oral CCI-779 Administered in Combination with Letrozole
versus Letrozole alone as First Line Hormonal Therapy in
Postmenopausal Women Locally Advanced or Metastatic Breast
Gastrointestinal Colon/Rectal SponsorProtocol # Study Title
PACCE: A Randomized, Open-Label, Controlled, Clinical Trial
of Chemotherapy and Bevacizumab With and Without
Panitumumab in the First-line Treatment of Subjects With
A Phase 3 Clinical Trial Comparing Infusional 5 Fluorouracil,
Leucovorin, and Oxaliplatin. Every Two Weeks with
Bevacizumab to the same Regimen without Bevacizumab for
thetreatment of Patients with Resected Stages 2 & 3 Carcinoma of
Wednesday, October 26, 2005 Page 2 of 10
A Randomized Phase III Trial of Irinotecan (CPT-11) and/or
Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF)
with or without Cetuximab (C225) after Curative Resection for
SponsorProtocol # Study Title
A Phase III Trial of Adjuvant Chemoradiation after Resection of
Gastric and Gastroesophageal Adenocarcinoma
SponsorProtocol # Study Title
Chemoembolization in Hepatocellular Carcinoma or
Neuroendocrine Hepatic Metastases: A Phase II Multi-Center
Pancreatic SponsorProtocol # Study Title
A Randomized Phase III Trial of Gemcitabine Plus Bevacizumab
(NSC#704865 IND#7921) versus Gemcitabine Plus Placebo in
Patients with Advanced Pancreatic Cancer
A Phase 2 Trial of Irinotecan/Docetaxel for Adv. Pancreatic
Cancer,with Randomization between Irinotecan/Docetaxel &
Irinotecan/Docetaxel Plus C225 a Monoclonal Antibody to the
Epidermal Growth Factor Receptor This study is suspended to
A Randomized Phase III Study of Gemcitabine in Combination
with Radiation Therapy versus Gemcitabine Alone in Patients
with Localized, Unresectable Pancreatic Cancer
A Randomized Phase 3 Study of the Efficacy and Safety of
Glufofsamide Compared with Best Supportive Care in Metastatic
Pancreatic Adenocarcinoma Previously Treated with Gemcitabine
Wednesday, October 26, 2005 Page 3 of 10 Genitourinary Prostate SponsorProtocol # Study Title
Intermittent Androgen Deprivation in Patients with Stage D2
Study of Epoetin Alfa vs Epoetin Alfa with Dexamethasone in
Hormone Refractory Prostate Cancer Patients: Impact on Fatigue,
Anemia, Functional Status and Quality of Life
Phase 3 Study of Satraplatin Plus Prednisone or Placebo Plus
Prednisone in Patients with Hormone Refractory Prostate Cancer
Previously Treated With One Cytotoxic Chemotherapy Regimen
SponsorProtocol # Study Title
A Phase 2 Trial Evaluating Atrasentan in Patients with Advanced
Renal Cell Cancer Note: Currently, this study is open only to
patients with non-measurable disease with bone metastases who
Phase II Trial of Doxorubicin and Gemcitabine in Metastatic
Renal Cell Carcinoma with Sarcomatoid Features
Phase II Trial of Paclitaxel Plus Carboplatin in Patients with
Metastatic or Locally Advanced Collecting Duct Renal Cell
Head & Neck Advanced Wednesday, October 26, 2005 Page 4 of 10 Protocol # Study Title
Phase II of PS-341 (NSC 681239) Followed by the Addition of
Suspended
Doxorubicin at Progression in Advanced Adenoid Cystic
Phase III Randomized, Placebo Controlled, Trial of Docetaxel
Versus Docetaxel Plus ZD1839 (Iressa, Gefitinib) in Performance
Status 2 or Previously Treated Patients with Recurrent or
Leukemia SponsorProtocol # Study Title
Phase III Randomized Trial of Autologous and Allogeneic Bone
Marrow Transplantation Versus Intensive Conventional
Chemotherapy in Acute Lymphoblastic Leukemia in First
Remission. Please offer ECOG 3903 to patients who consent to
SponsorProtocol # Study Title
A Phase III Trial in Adult Acute Myeloid Leukemia:
Daunorubicin Dose-Intensification and Gemtuzumab-Ozogamicin
Consolidation Therapy prior to Autologous Stem Cell
Transplantation Please offer ECOG 3903 to patients who
A Phase III Randomized Study of Farnesyl Transferase Inhibitor
R115777 in Acute Myeloid Leukemia (AML) Patients in Second
or Subsequent Remission or in Remission after Primary
Phase II Studies of Two Different Schedules and Two Different
Doses of The Farnesyl Transferase Inhibitor R 115777
(Tipifarnib, Zarnestra, NSC-702818) for Previously Untreated
Acute Myeloid Leukemia (AML) In Patients of Age 70 or Older
Wednesday, October 26, 2005 Page 5 of 10 CLL Sponsor Protocol # Study Title
Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab
(PCR) Followed By Campath-1H For Previously Treated
Relapsed or Refractory Patients With Chronic Lymphocytic
SponsorProtocol # Study Title
A Phase IIb Study of Molecular Responses to Imatinib at
Standard or Increased Doses for Previously Untreated Patients
With Chronic Myelogenous Leukemia (CML) in Chronic Phase
LABORATORY SponsorProtocol # Study Title
Ancillary Laboratory Protocol for Collecting Diagnostic Material
on Patients Considered for ECOG Treatment Trials for Leukemia
Miscellaneous SponsorProtocol # Study Title
A Phase II Study of Initial Treatment with Methotrexate in Large
Non-Small Cell SponsorProtocol # Study Title
A Randomized Multicenter Phase II Study of
Taxane/Carbo/Cetuximab versus Taxane/Carbo as First-Line
treatment for Patients with Advanced/Metastatic Non-Small Cell
A Phase III Trial of Carboplatin, Paclitaxel and Thoracic
Radiotherapy With or Without Thalidomide, in Patients with
Wednesday, October 26, 2005 Page 6 of 10
A Double Blind Phase II Study of BAY-43-9006 in Patients with
Suspended
Non-Small Cell Lung Cancer who have Failed at Least Two
A Phase II Trial of Induction Chemoradiotherapy with
Cisplatin/Etoposide Followed by Surgical Resection, Followed
by Docetaxel, for Non-Small Cell Lung Cancer Involving the
BETA: Phase III / Double-Blind / Placebo-Controlled Trial of
Bevacizumab in Combination with Tarceva Compared with
Tarceva Alone rfor Treatment of Advanced Non-Small Cell Lung
Cancer After Failure of Standard First Line Chemo
Molecular Profiling of Non-Small cell Lung Cancer with Clinical
Phase I/II Study of Gemcitabine, Carboplatin and Concurrent
Suspended
Radiation Therapy in Stage III Non-Small Cell Lung Cancer
SponsorProtocol # Study Title
Phase III Chemoprevention Trial of Selenium Supplementation in
Persons with Resected Stage I Non-Small Cell Lung Cancer
Small Cell SponsorProtocol # Study Title
Interferon Alpha (NSC#377 523) Plus 13-Cis-Retinoic Acid
Modulation of BCL-2 Plus Paclitaxel for Recurrent Small Cell
Wednesday, October 26, 2005 Page 7 of 10 Protocol # Study Title
Phase II Study of Carboplatin plus Paclitaxel Treatment of
Lymphoma Hodgkin's SponsorProtocol # Study Title
A Randomized Phase III Trial of ABVD Versus Stanford V +
Radiation Therapy in Locally Extensive and Advanced Stage of
Non-Hodgkin's SponsorProtocol # Study Title
Randomized Phase III Trial Comparing Two Different Rituximab
Dosing Regimens for Low Tumor Burden Patients with Indolent
A Randomized Phase III Trial of Rituximab (NSC #687451) and
Autologous Stem Cell Transplantation for B Cell Diffuse Large
Early High Dose Chemoradiotherapy and ASCT to Conventional
Dose CHOP Chemotherapy (with possible Late ASCT) for
A Phase II Trial of R-CHOP Followed By Zevalin
Radioimmunotherapy for Patients with Previously Untreated
Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's
Wednesday, October 26, 2005 Page 8 of 10 Melanoma High Risk Protocol # Study Title
Phase III Trial of High Dose Interferon Alpha-2b Versus
Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients
Randomized Study of Four Weeks High Dose Interferon Alpha-2b
Yeast Derived GM-CSF Versus Peptide Vaccination Vs.
GM-CSF Plus Peptide Vaccination Versus Placebo in Patients
with "No Evidence of Disease" After Complete Surgical Resection
of "Locally Advanced" and/or Stage IV Melanoma
Metastatic SponsorProtocol # Study Title
A Randomized Phase II Trial of Multi-epitope Vaccination with
Melanoma Peptides for Cytotoxic T cells and Helper T cells for
Phase II Study of Low Dose Peginterferon Alfa-2b in Patients
with Metastatic Melanoma Over-Expressing Basic Fibroblast
Miscellaneous SponsorProtocol # Study Title
ECOG Laboratory Study: Mapping Interactive Cancer
Wednesday, October 26, 2005 Page 9 of 10 Anemia Sponsor Protocol # Study Title
FLEXIBILITY: Impact of Once per Cycle Correction and
Maintenance Dosing of Darbepoetin Alfa in Subjects with
Non-Myeloid Malignancies with Anemia due to Chemo
Catheter Occlusion SponsorProtocol # Study Title
SONOMA 2: Double-Bline, Placebo-Controlled Study to
Evaluate the Efficacy and Safety of Alfimeprase in Subjects with
Multiple Myeloma SponsorProtocol # Study Title
A Randomized Phase III Study of CC-5013 plus Dexamethasone
Suspended
versus CC-5013 plus Low Dose Dexamethasone in Multiple
Myeloma with Thalidomide plus Dexamethasone Salvage
SponsorProtocol # Study Title
A Phase III Randomized Double-blind Study of Adjuvant STI571
(Gleevec) Versus Placebo in Patients Following the Resection of
Primary GastroIntestinal Stromal Tumor (GIST) (ECOG
A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (Gleevec) for
Primary and Recurrent Operable Malignant GIST Expressing the
Wednesday, October 26, 2005 Page 10 of 10
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