Trial & Business Updates:

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Priority Lists

Activations

S0217Phase II
Adjuvant Chemo-Radiotherapy with Combination of Cisplatin (NSC-119875)and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Coordinator(s)Prakash C. Neupane, M.D., Harold Kim, M.D., Stephen K. Williamson, M.D., George Yoo, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
S0431Phase II
Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
Study Coordinator(s)Madeleine Kane, M.D., Ph.D, Adel K. El-Naggar, M.D., Ph.D, Stephen K. Williamson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG
S0435Phase II

Activation

A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Barbara J. Gitlitz, M.D., Bonnie S. Glisson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
Nonmyeloablative Allogeneic Stem Cell Transplantation for Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation (A BMT Study)
Study Coordinator(s)Scott E. Smith, M.D., Ph.D, Patrick J. Stiff, M.D.
ParticipantsLimited Institutions: Allogeneic BMT Members

Closures

JPR3Phase III Intergroup

Permanent Closure

Intergroup (NCIC CTG, CUOG, ECOG, CALGB, SWOG) Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3 - 4, N0, M0 Adenocarcinoma of the Prostate
Action CodesER
Study Coordinator(s)Gregory P. Swanson, M.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, Pathologists, NCORP, Members
Closure Date2005-08-31

Amendments, Revisions, Memoranda

E4697Phase III Intergroup

Revision #5

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with "No Evidence of Disease" after Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Action CodesIP, AC, ER
Study Coordinator(s)Kim A. Margolin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
R9813Phase IIb

Revision #4

A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
Study Coordinator(s)Geoffrey R. Barger, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0202Phase II

Memorandum

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
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
S0303Phase III

Memorandum

A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer
Study Coordinator(s)Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0313Phase II

Revision #5

Evaluation of CHOP Plus Involved Field Radiotherapy followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE and non-bulky Stages II and IIE, CD20 Positive, High-risk Localized, Aggressive Histologies of Non-Hodgkin's Lymphoma, Phase II
Study Coordinator(s)Thomas P. Miller, M.D., Louis S. Constine, M.D., B. Dino Stea, M.D.,Ph.D., Catherine Spier, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0342Phase II

Memorandum

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0415Phase II

Amendment #2

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP

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