Trial & Business Updates:

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Priority Lists

Activations

Activation (Southwest Oncology Group endorsement of CTSU menu protocol - available electronically only.)

A Three-Arm Randomized Trial To Compare Adjuvant Adriamycin, Taxotere, and Cyclophosphamide (ATC) in Breast Cancer Patients With Positive Axillary Lymph Nodes
Study Coordinator(s)Robert B. Livingston, M.D.
ParticipantsCTSU
S0002Phase III Intergroup
Smoking Cessation Intervention (Including Bupropion-Zyban Versus Placebo) for Completely Resected Stage I and Stage II Non-Small Cell Lung Cancer Survivors Who Are Currently Smokers, Phase III
Study Coordinator(s)Ellen R. Gritz, Ph.D., Linda Sarna, R.N., DNSc
ParticipantsMembers, Medical Oncologists, NCORP, CALGB, ECOG
S0119Phase II

Activation

Phase II Trial of Gemcitabine and Irinotecan in Patients with Untreated Extensive Stage Small Cell Lung Cancer (SCLC)
Study Coordinator(s)Wallace L. Akerley, M.D., Paul J. Hesketh, M.D.
ParticipantsMembers, NCORP, Medical Oncologists

Closures

S0014Phase II

Permanent Closure: 1/15/02

Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High Risk Localized Aggressive Histologies of Non-Hodgkin’s Lymphoma, Phase II
Study Coordinator(s)Thomas P. Miller, M.D., B. Dino Stea, M.D.,Ph.D., Catherine P. Leith, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
Closure Date2002-01-15

Amendments, Revisions, Memoranda

G0182Phase III Intergroup

SWOG Revision #1 regarding GOG Revsions #4-6

A Phase III Randomized Trial of Paclitaxel and Carboplatin Versus Triplet or Sequential Doublet Combinations in Patients with Epithelial Ovarian or Primary Peritoneal Carcinoma.
Study Coordinator(s)Amy D. Tiersten, M.D.
ParticipantsNCORP, Members, Surgeons, Pathologists
JMA17Phase III Intergroup

Memorandum and Revision #4

A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Study Coordinator(s)Silvana Martino, D.O.
S0026Phase II

Amendment #1

Evaluation of Interferon Alpha-2b and Thalidomide in Patients with Disseminated Malignant Melanoma, Phase II
Study Coordinator(s)Laura F. Hutchins, M.D., Joseph I. Clark, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0027Phase II

Revision #4

Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or with Performance Status 2
Study Coordinator(s)Paul J. Hesketh, M.D., Derick H.M. Lau, M.D.,Ph.D., James H. Doroshow, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0028Phase II

Revision #1

Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (And in a Cohort of Patients Younger Than 60 Years)
Study Coordinator(s)Derek Raghavan, M.D.,Ph.D., Maha H.A. Hussain, M.D., Daniel P. Petrylak, M.D., Carolyn C. Gotay, Ph.D., Dorothy Coleman, R.N., M.S., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
S0111Phase II

Revision #3

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients with Hormone Refractory Prostate Cancer
Study Coordinator(s)Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Wael A. Sakr, M.D., Michael A. Tainsky, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S9915Phase II

Memo

A Phase II Study of PN401, 5-FU, and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach.
Study Coordinator(s)James H. Doroshow, M.D., John S. Macdonald, M.D.
ParticipantsMembers, NCORP
S9916Phase III Intergroup

Amendment #1

Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer, Phase III.
Study Coordinator(s)Daniel P. Petrylak, M.D., Jeffrey A. Jones, M.D., Maha H.A. Hussain, M.D., Donna L. Berry, R.N.,Ph.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, CALGB, NCCTG, EPP, NCORP, Members, CTSU
  • 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