Trial & Business Updates:

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Priority Lists

Activations

G0137Phase III Intergroup

Activation Notice

A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
ParticipantsMembers, NCORP, Surgeons, Pathologists
S0029Phase II

ACTIVATION

Single Agent Docetaxel For Metastatic Breast Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)
Study Coordinator(s)Silvana Martino, D.O., Dorothy Coleman, R.N., M.S., Carolyn C. Gotay, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
S0112Phase II
S0112, A Phase II Study Of Daunomycin And Ara-C, Both Given By Continuous IV Infusion 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., Alan F. List, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists

Closures

E4494Phase III Intergroup

Permanent Closure effective 7/12/01

Phase III Trial of CHOP versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients with Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma
Study Coordinator(s)James K. Weick, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP
Closure Date2001-07-12
S0004Phase I

Temporary Closure effective 8/15/01

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
Closure Date2002-04-01
S0033Phase III Intergroup

PERMANENT CLOSURE Effective 9/1/01

"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"
Study Coordinator(s)George Demetri, M.D., Christopher Fletcher, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG
Closure Date2001-09-01
SWOG-9419Ancillary

Permanent Closure effective 8/15/01

Tumor Tissue Biopsy for Thymidylate Synthase Expression in Patients with Colorectal Cancer, Ancillary
Study Coordinator(s)Lawrence P. Leichman, M.D.
ParticipantsMembers, Pathologists, NCORP
Closure Date2001-08-15

Amendments, Revisions, Memoranda

C19801Phase II Intergroup

Revision #1

A Phase II Study of 506U78 in Patients with Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)
Study Coordinator(s)Steven E. Coutre, M.D., Alison T. Stopeck, M.D.
ParticipantsPathologists, NCORP, Members
C89803Phase III Intergroup

SWOG Revision #4 regarding CALGB Update #4

A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC-616348) Plus Fluorouracil/Leucovorin (5FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection For Patients With Stage III Colon Cancer.
Study Coordinator(s)Alexander Hantel, M.D.
ParticipantsPathologists, NCORP, Members
N9741Phase III Intergroup

SWOG Memo regarding NCCTG Safety Reports

A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) as Initial Treatment of Patients With Advanced Adenocarcinoma of the Colon and Rectum
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, Surgeons, NCORP
S0003Phase III

Revision #4

Randomized Phase III Trial of Carboplatin and Paclitaxel plus Tirapazamine versus Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer Cisplatin, Paclitaxel, Tirapazamine vs. Cisplatin, Paclitaxel Specimen submission per S9925
Study Coordinator(s)Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, EPP, CTSU
S0009Phase II

Revision #2

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
S0010Phase II

Amendment #2

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-Cell Acute Lymphoblastic Leukemia (ALL)
Study Coordinator(s)Steven E. Coutre, M.D., David R. Head, M.D., David H. Boldt, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
SWOG-9411Phase III Intergroup

SWOG revision #17 regarding NCCTG Addendum #11

A Phase III Prospective Randomized Trial Comparing Laparoscopic - Assisted Colectomy Versus Open Colectomy for Colon Cancer
Study Coordinator(s)Robert W. Beart, M.D., John Vetto, M.D.

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