Trial & Business Updates:

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Priority Lists

Activations

S0310Phase II
Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC).
Study Coordinator(s)Angela M. Davies, M.D., Raja Mudad, M.D., FACP, Peter F. Roberts, M.D., Derick H.M. Lau, M.D.,Ph.D., Deborah S. Ward, NP
ParticipantsLimited: Institutions Listed on the Title Page
S0349Phase II

Activation

Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) with Advanced Stage Diffuse Large B-cell NHL of Low and Low-Intermediate IPI Risk
Study Coordinator(s)Steven Bernstein, M.D., Richard I. Fisher, M.D., Thomas M. Grogan, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists

Closures

Permanent closure effective 3/31/04

A Three-Arm Randomized Trial To Compare Adjuvant Adriamycin, Taxotere, and Cyclophosphamide (ATC) in Breast Cancer Patients With Positive Axillary Lymph Nodes
Study Coordinator(s)Robert B. Livingston, M.D.
ParticipantsCTSU
Closure Date2004-03-31

Permanently closed: 2/18/04

A Randomized, Placebo-controlled, Double-blind Trial Evaluating the Effect of Exemestane in Clinical cT1-3NO-1MO Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy
Study Coordinator(s)Laura F. Hutchins, M.D.
ParticipantsCTSU
Closure Date2004-02-18

Permanent closure effective 3/31/04

A Clinical Trial Comparing Adjuvant Clodronate Therapy vs Placebo in Early Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Tamoxifen or No Therapy
Action CodesIP, ER
Study Coordinator(s)Julie R. Gralow, M.D.
ParticipantsCTSU
Closure Date2004-03-31

Amendments, Revisions, Memoranda

Revision #4

Phase III Randomized Trial of Fludarabine and Cyclophosphamide versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia.
Study Coordinator(s)Mohamad A. Hussein, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
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.
S0000Phase III

Memorandum

Selenium and Vitamin E Cancer Prevention Trial (SELECT)
Study Coordinator(s)Eric A. Klein, M.D., Ian M. Thompson Jr., M.D., Wael A. Sakr, M.D.
ParticipantsInstitutions listed in protocol Appendix 19.5
S0009Phase II

Revision #9

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
S0023Phase III Intergroup

Revision #11

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
S0025Phase II

Revision #1

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
S0117Phase II

Revision #4

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg™) and Standard Dose Ara-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
Study Coordinator(s)John E. Godwin, M.D., Margaret R. O'Donnell, M.D., David R. Head, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0121Phase II

Amendment #1

Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients with Locally Advanced or Recurrent Urothelial Malignancy
Study Coordinator(s)Ulka N. Vaishampayan, M.D., Maha H.A. Hussain, M.D., Jeffrey D. Forman, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
S0121Phase II

Revision #1

Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients with Locally Advanced or Recurrent Urothelial Malignancy
Study Coordinator(s)Ulka N. Vaishampayan, M.D., Maha H.A. Hussain, M.D., Jeffrey D. Forman, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
S0202Phase II

Revision #1

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients with Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
Study Coordinator(s)Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0204Phase II

Memorandum

A Phase II Trial of Thalidomide/Dexamethasone Induction Followed by Tandem Melphalan Transplant and Prednisone/Thalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients, (A BMT Study)
Action CodesER
Study Coordinator(s)Mohamad A. Hussein, M.D., John D. Shaughnessy, Jr., Ph.D., James A. Waldron, M.D.,Ph.D., Jeffrey A. Zonder, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Limited Institutions: BMT Members
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0205Phase III

Revision #1

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0355Phase I

Amendment #1

A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
Study Coordinator(s)Angela M. Davies, M.D., Timothy W. Synold, Pharm. D., Chris Takimoto, M.D.
ParticipantsLimited: Institutions Listed on the Title Page

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