Trial & Business Updates:

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Priority Lists

Activations

Closures

S0032Phase II

Permanent Closure Effective 6/1/2005

Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination with Hormone Therapy in Patients with High-Risk Metastatic Adenocarcinoma of the Prostate
Study Coordinator(s)David C. Smith, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons
Closure Date2005-06-01
S0121Phase II

Permanent Closure Effective 6/1/2005

Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients with Locally Advanced or Recurrent Urothelial Malignancy
Study Coordinator(s)Ulka N. Vaishampayan, M.D., Maha H.A. Hussain, M.D., Jeffrey D. Forman, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
Closure Date2005-06-01
S0125Phase II

Permanent Closure Effective June 1, 2005

A Phase II Study of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation in Older Patients With Acute Myeloid Leukemia (AML) in First Complete Remission (A BMT Study)
Study Coordinator(s)Peter A. McSweeney, M.D., Thomas R. Chauncey, M.D.,Ph.D., Scott I. Bearman, M.D., Anwar N. Mohamed, M.D., Cheryl L. Willman, M.D.
ParticipantsLimited Institutions: Allogeneic BMT Members
Closure Date2005-06-01
S9811Phase II

Permanent closure effective 6/1/05

Phase II Study of Hydroxyurea for Unresectable Meningioma
Study Coordinator(s)Lode J. Swinnen, M.D., Geoffrey R. Barger, M.D., Elisabeth J. Rushing, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, ECOG
Closure Date2005-06-01

Amendments, Revisions, Memoranda

S0012Phase III

Memorandum

A Comparative Randomized Study of Standard Doxorubicin And Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin And Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory And Locally Advanced Breast Cancer
Study Coordinator(s)Georgiana K. Ellis, M.D., Robert B. Livingston, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, EPP, CTSU
S0114Phase I-II

Amendment #2

An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
Study Coordinator(s)Robert B. Montgomery, M.D., Mary L. Disis, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0124Phase III

Memorandum

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S0200Phase III

Memorandum

A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy
Study Coordinator(s)Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU Institutions in the United States
S0202Phase II

Revision #3

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients with Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
Study Coordinator(s)Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0220Phase II Intergroup

Amendment #2

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 Superior Sulcus (Pancoast Tumors)
Study Coordinator(s)Michael J. Kraut, M.D., Katherine M. W. Pisters, M.D., Joshua Sonett, M.D., Charles R. Thomas Jr., M.D., Valerie W. Rusch, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG, NCIC-CTG, ACOSOG, NCCTG, CALGB
S0220Phase II Intergroup

Amendment #2

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 Superior Sulcus (Pancoast Tumors)
Study Coordinator(s)Michael J. Kraut, M.D., Katherine M. W. Pisters, M.D., Joshua Sonett, M.D., Charles R. Thomas Jr., M.D., Valerie W. Rusch, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG, NCIC-CTG, ACOSOG, NCCTG, CALGB
S0221Phase III

Amendments #1 and #2; Memorandum

"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 Cancer"
Study Coordinator(s)G. Thomas Budd, M.D., Halle C.F. Moore, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S0230Phase III

Amendment #4

Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Study Coordinator(s)Halle C.F. Moore, M.D., Silvana Martino, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CALGB, ECOG, IBCSG
S0303Phase III

Memorandum

A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer
Study Coordinator(s)Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0309Ancillary

Revision #5

Myeloma Specimen Repository Protocol, Ancillary
Action CodesER
Study Coordinator(s)Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists

Revision #3

Barriers to Accrual to Clinical Trials in Older (>= 65 Years) Cancer Patients
Study Coordinator(s)Julie R. Gralow, M.D., Antoinette J. Wozniak, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0342Phase II

Memorandum

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0342Phase II

Revision #3

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0414Phase II

Memorandum

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Study Coordinator(s)Charles R. Thomas Jr., M.D., Charles D. Blanke, M.D., James L. Abbruzzese, M.D., Lisa Hammond, M.D., Vivek Mehta, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons
S0415Phase II

Memorandum

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP
SWOG-8624Phase III

Memorandum

A Phase III Randomized Trial of Combination Therapy for Multiple Myeloma; Comparison of (1) VMCP/VBAP to VAD or VMCPP/VBAPP for Induction; (2) Alpha-2b Interferon or No Therapy for Maintenance; and 3) Alpha-2b Interferon + Dexamethasone for Incomplete or Non-Responders; and (4) VAD Plus Verapamil For Incomplete or Non-Responders on VAD
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D., Sheikh Saeed, M.D.
SWOG-8993Phase II

Memorandum

Phase II Study of High Dose Melphalan with Hemopoietic Stem Cell Support and GM-CSF in Refractory Multiple Myeloma (MM)
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D.
SWOG-9028Phase III

Memorandum

A Phase III Randomized Trial of Combination Therapy for Multiple Myeloma Comparison of (1) VAD to VAD/ Quinine for Induction with Crossover to VAD/ Quinine for VAD Induction Failures; (2) Alpha-2b Interferon or Alpha-2b Interferon plus Prednisone for Remission Maintenance
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D., Thomas M. Grogan, M.D.
  • IP - Pts Must Be Informed
  • AC - Consent Must Be Amended
  • CBR - No Registration Allowed until IRB Review
  • RC - Formal Re-consent Required
  • FBR - Full Board Review Required
  • ER - Expedited Review Acceptable
  • NR - No IRB Review Required