Trial & Business Updates:

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Priority Lists

Activations

A Phase III Trial Evaluating the Role of Ovarian Function Supression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
Action CodesER
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsCTSU
A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Repsonsive Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsCTSU
A Randomized Phase III Trial of Exemestane Versus Anastrozole With or Without Celecoxib in Postmenopausal Women With Receptor Positive Primary Breast Cancer
Action CodesER
Study Coordinator(s)G. Thomas Budd, M.D.
ParticipantsCTSU
S0322Phase I

Activation

Single Agent ZD-1839 in Patients With Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older (and in a Cohort of Patients 50 Years Old and Younger), Pharmacology.
Study Coordinator(s)Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D.
ParticipantsLimited: Institutions Listed on the Title Page

Closures

S0127Phase II

Permanent Closure

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
Closure Date2003-08-15
S9926Phase II

Permanent Closure

Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
Study Coordinator(s)Raymond A. Kempf, M.D., MPH
ParticipantsMembers, Medical Oncologists, NCORP
Closure Date2003-09-01

Amendments, Revisions, Memoranda

4B951Phase III Intergroup

Amendment #1

MVAC in Organ-Confined Bladder Cancer Based on p53 Status
Study Coordinator(s)Seth P. Lerner, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists
N9841Phase III Intergroup

Revision #9

A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, Surgeons, NCORP
S0011Phase II

Revision #2

Phase II Trial of Surgery with Perioperative INGN 201 (Ad5CMV-p53) Gene Therapy Followed by Chemoradiotherapy for Advanced, Resectable Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx and Larynx
Study Coordinator(s)George Yoo, M.D., S.G. Urba, M.D., Harold Kim, M.D., Ehab Hanna, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0023Phase III Intergroup

Memorandum

A Phase III Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation Docetacel followed by Maintenance Therapy with ZD1839 (NSC-715055) or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Study Coordinator(s)Karen Kelly, M.D., Laurie E. Gaspar, M.D., Wilbur A. Franklin, M.D., David R. Gandara, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, NCCTG, NCIC-CTG, CTSU, EPP
S0030Phase II

Memorandum

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
S0124Phase III

Revision #3

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S0126Phase II

Memorandum

Phase II Trial of Chronic Oral ZD1839 (Iressa) in Both Previously-Untreated and Previously-Treated Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Study Coordinator(s)Howard (Jack) West, M.D., Ralph B. Vance, M.D., Wilbur A. Franklin, M.D., Derick H.M. Lau, M.D.,Ph.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S9912Phase II

Revision #16

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
SWOG-9442Phase III Intergroup

Revision #13

Randomized Multi-Institutional Phase III Trial of BEP and High Dose Chemotherapy Versus BEP Alone in Previously Untreated Patients With Poor and Intermediate Risk Germ Cell Tumors
Study Coordinator(s)Kim A. Margolin, M.D., Patrick J. Stiff, M.D., Michael F. Sarosdy, M.D.
ParticipantsLimited Institutions: SWOG Approved Autologous BMT Facilities

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