Trial & Business Updates:

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Priority Lists

Activations

Closures

G0175Phase III Intergroup

Permanent Closure

A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days X 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days X 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma.
Study Coordinator(s)Carolyn M. Johnston, M.D.
ParticipantsMembers, NCORP
Closure Date2003-08-15
S0025Phase II

Permanent Closure

Phase II Trial of Irinotecan (Camptosar) for Patients with Platinum and Taxane Refractory Ovarian, Peritoneal or Fallopian Tube Cancer
Study Coordinator(s)Amy D. Tiersten, M.D., William R. Robinson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
Closure Date2003-08-15
S0227Phase III

Permanent Closure

Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix
Study Coordinator(s)Harry Long, M.D., Maurie Markman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CTSU
Closure Date2003-07-28

Amendments, Revisions, Memoranda

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
S0030Phase II

Revision #1

Protocol for Assessment of Capecitabine for Advanced Colorectal Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger than 60 Years)
Study Coordinator(s)Heinz- Josef Lenz, M.D., Derek Raghavan, M.D.,Ph.D., Carolyn C. Gotay, Ph.D., Dorothy Coleman, R.N., M.S.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
SWOG-9346Phase III Intergroup

Revision #18

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

Other New Items

  • 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