Trial & Business Updates:

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Priority Lists

Activations

S0120Biologic

ACTIVATION

A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasma Proliferative Disorders
Study Coordinator(s)Madhav V. Dhodapkar, M.D., Bart Barlogie, M.D.,Ph.D., John D. Shaughnessy, Jr., Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0127Phase II

Activation

A Phase II Study of OSI-774 (NSC #718781) in Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction
Study Coordinator(s)Tomislav Dragovich, M.D., Ph.D, James L. Abbruzzese, M.D.
ParticipantsMembers, NCORP

Closures

C9581Phase III Intergroup

Permanent Closure and Revision #6

Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A vs. No Adjuvant Therapy Following Resection for Stage II (Modified Astler - Coller B2) Adenocarcinoma of the Colon.
Study Coordinator(s)R.L. Martino, M.D.
ParticipantsMembers, Surgeons, Pathologists, NCORP
Closure Date2002-05-31

Amendments, Revisions, Memoranda

G0137Phase III Intergroup

Revision #3

A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma
ParticipantsMembers, NCORP, Surgeons, Pathologists
N9741Phase III Intergroup

Memorandum

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
S0009Phase II

Revision #5

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 #4

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
S0013Biologic

Revision #2

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
S0026Phase II

Amendment #2

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 #5

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
S0107Phase II

Revision #6

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP
S0111Phase II

Memorandum

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
S0207Phase II

Revision #2

Phase II Study of Arsenic Trioxide in Male Patients with Refractory Germ Cell Malignancies
Study Coordinator(s)Tomasz M. Beer, M.D., Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons
S0218Phase II

Amendment #2

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) In Patients with Malignant Pleural Mesothelioma
Study Coordinator(s)Linda L. Garland, M.D., Michael Lobell, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9912Phase II

Revision #6

Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Study Coordinator(s)Harriet O. Smith, M.D., Amy D. Tiersten, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Surgeons, Pathologists, NCORP
S9922Phase III

Amendment #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
  • 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