Trial & Business Updates:

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Priority Lists

Activations

S0009Phase II

Activation Notice

Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer
Study Coordinator(s)Amy D. Tiersten, M.D., Harriet O. Smith, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Surgeons
S0022Phase II
Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer
Study Coordinator(s)Raja Mudad, M.D., FACP, Laurie E. Gaspar, M.D., R. Chapman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists

Closures

S9918Phase II

Permanent Closure

A Phase II Study of Daunomycin and Ara-C Given by Continuous IV Infusion with PSC-833 for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older
Study Coordinator(s)Thomas R. Chauncey, M.D.,Ph.D., John E. Godwin, M.D., Alan F. List, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Jacqueline R. Batanian, Ph.D.
ParticipantsPathologists, NCORP, Members
Closure Date2001-03-15

Amendments, Revisions, Memoranda

G0175Phase III Intergroup

SWOG Revision #1 regarding GOG Revsion #6. New procedure for SWOG patient registration. GOG Form T included.

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
JMA17Phase III Intergroup

MEMORANDUM

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.
S0004Phase I

Revision #2

A Phase I Study of Tirapazamine/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
Study Coordinator(s)Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Janice Ryu, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0013Biologic

Memo regarding tissue processing and patient billing.

Evaluation of In Vitro Assays as Predictors of Clinical Outcome in Patients With Locally Advanced (Stage IIB-IVA)Cervical Carcinoma, Biologic
Study Coordinator(s)Robert A. Burger, M.D., Bradley J. Monk, M.D., Sharon Wilczynski, M.D.,Ph.D., Robert S. Lavey, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
S0019Phase III

Revision #2

A Randomized Phase III Trial of ICE Chemotherapy With or Without Rituximab for the Treatment of Relapsed or Refractory CD20 Expressing Agressive B-Cell Non-Hodgkin's Lymphomas in Patients Not Suitable for High Dose Therapy and PBSCT.
Study Coordinator(s)David G. Maloney, M.D.,Ph.D., Thomas P. Miller, M.D., Thomas M. Grogan, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S9902Phase II

Revision #4

Evaluation of the Combination of Docetaxel (Taxotere®)/ Carboplatin in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Phase II
Study Coordinator(s)Wolfram E. Samlowski, M.D., J. Philip Kuebler, M.D.,Ph.D.
ParticipantsMembers, Medical Oncologists, NCORP
S9922Phase III

Revision #4

A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients with Refractory Multiple Myeloma
Study Coordinator(s)Mohamad A. Hussein, M.D., James K. Weick, M.D.
ParticipantsNCORP, Members

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