Trial & Business Updates:

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Priority Lists

Activations

S0000CPhase III

Activation 6/4/04

Prevention of Lung Function Decline with Vitamin E and Selenium - Respiratory Ancillary Study (RAS) to SELECT
Study Coordinator(s)Patricia A. Cassano, Ph.D., Alan Kristal, Dr.P.H.
ParticipantsLimited: Institutions Listed on the Title Page
S0338Phase II
Phase II Trial of Imatinib Mesylate (Gleevec) (NSC-716051) In Combination With Capecitabine (Xeloda) (NSC-712807) In Metastatic Breast Cancer
Study Coordinator(s)Helen K. Chew, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0400Phase II

Activation

A Phase II Study of Depsipeptide (NSC-630176) in Patients with Advanced Transitional Cell Carcinoma of the Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen for Advanced Disease
Study Coordinator(s)Daniel P. Petrylak, M.D., Guru Sonpavde, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists

Closures

CTSU/E2100Phase III
A Randomized Phase III Trial of Paclitaxel versus Paclitaxel plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer
Study Coordinator(s)Julie R. Gralow, M.D.
ParticipantsCTSU
Closure Date2004-05-26
SWOG-9438Phase III
Total Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkin's Lymphoma, A BMT Study, Phase III
Study Coordinator(s)Alexander Fefer, M.D., John A. Thompson, M.D., Patricia K. Lillis-Hearne, M.D.
ParticipantsLimited Institutions: BMT Members
Closure Date2004-07-01

Amendments, Revisions, Memoranda

4B951Phase III Intergroup

Memorandum

MVAC in Organ-Confined Bladder Cancer Based on p53 Status
Study Coordinator(s)Seth P. Lerner, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists
4B951Phase III Intergroup

Revision #1

MVAC in Organ-Confined Bladder Cancer Based on p53 Status
Study Coordinator(s)Seth P. Lerner, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists
S0012Phase III
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
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
S0303Phase III

Amendment #1

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
S0322Phase I

Revision #2

Single Agent ZD-1839 in Patients With Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older (and in a Cohort of Patients 50 Years Old and Younger), Pharmacology.
Study Coordinator(s)Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D.
ParticipantsLimited: Institutions Listed on the Title Page
S0331Phase II

Amendment #2

A Phase II Trial of STI-571/Imatinib (GleevecĀ®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Study Coordinator(s)Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG
S9910Ancillary

Revision #8

Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary
Action CodesER
Study Coordinator(s)Cheryl L. Willman, M.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU, Affiliates

Revision #26

Cytogenetic Studies in Leukemia Patients
Action CodesER
Study Coordinator(s)Diane Roulston, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU, Affiliates
SWOG-9346Phase III Intergroup

Amendment #7

Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III
Study Coordinator(s)Maha H.A. Hussain, M.D., Celestia S. Higano, M.D., Brian J. Miles, M.D., Paul H. Lange, M.D., E. David Crawford, M.D., Donna L. Berry, R.N.,Ph.D., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, EORTC, EPP, NCIC-CTG
SWOG-9346Phase III Intergroup

Revision #19

Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III
Study Coordinator(s)Maha H.A. Hussain, M.D., Celestia S. Higano, M.D., Brian J. Miles, M.D., Paul H. Lange, M.D., E. David Crawford, M.D., Donna L. Berry, R.N.,Ph.D., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, EORTC, EPP, NCIC-CTG
  • 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