Trial & Business Updates:

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Priority Lists

Activations

S0224Phase II

Activation

Phase II Study of Weekly Docetaxel in Patients with Advanced Epidermoid Carcinoma of the Penis
Study Coordinator(s)Tomasz M. Beer, M.D., Christopher W. Ryan, M.D., Daniel J. Culkin, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, ECOG
S0232Phase III

Activation

Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Previously Untreated Multiple Myeloma who are Not Immediately Undergoing Autologous Stem Cell Transplant
Study Coordinator(s)Jeffrey A. Zonder, M.D., Bart Barlogie, M.D.,Ph.D., Muneer H. Abidi, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0415Phase II

Activation

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

Closures

Amendments, Revisions, Memoranda

CTSU/E1697Phase III Intergroup

Revision #5

Phase III Randomized Study of Four Weeks of High Dose IFN-alpha2b in Stage T2b N0, T3a-b N0, T4a-b N0, and T1-4, N1a, 2a, 3(Microscopic) Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsCTSU
E4697Phase III Intergroup

Revision #3

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
S0008Phase III Intergroup

Revision #15

Phase III Trial of High Dose Interferon Alpha-2b versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D., John A. Thompson, M.D., Ralph J. Tuthill, M.D., John Vetto, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, ECOG, COG, US INSTITUTIONS ONLY
S0028Phase II

Revision #4

Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (And in a Cohort of Patients Younger Than 60 Years)
Study Coordinator(s)Derek Raghavan, M.D.,Ph.D., Maha H.A. Hussain, M.D., Daniel P. Petrylak, M.D., Carolyn C. Gotay, Ph.D., Dorothy Coleman, R.N., M.S., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
S0121Phase II

Revision #2

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
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
S0219Phase II

Revision #3

A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin with Molecular Correlates
Study Coordinator(s)Primo N. Lara, Jr., M.D., Ralph W. deVere White, M.D., Jeffrey P. Gregg, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Pathologists, Surgeons
S0220Phase II Intergroup

Revision #3

A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)
Study Coordinator(s)Michael J. Kraut, M.D., Katherine M. W. Pisters, M.D., Joshua Sonett, M.D., Charles R. Thomas Jr., M.D., Valerie W. Rusch, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG, NCIC-CTG, ACOSOG, NCCTG, CALGB
S0306Phase II

Revision #2

Phase II Study of Irinotecan in Patients with Advanced Transitional Cell Carcinoma of the Urothelium
Study Coordinator(s)Tomasz M. Beer, M.D., Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons
S0309Ancillary

Revision #4

Myeloma Specimen Repository Protocol, Ancillary
Action CodesER
Study Coordinator(s)Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0310Phase II

Amendment #2

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
S0322Phase I

Amendment #2

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
S0331Phase II

Revision #2

A Phase II Trial of STI-571/Imatinib (GleevecĀ®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Study Coordinator(s)Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG
S0342Phase II

Revision #1

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
S0349Phase II

Amendment #1

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
S0420Phase II

Revision #1

Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients with Recurrent or Metastatic Head and Neck Cancer
Study Coordinator(s)Stephen K. Williamson, M.D., Chao Hui Huang, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9908Phase III

Revision #5

A Double-Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of L-Glutamine (in AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis in Head and Neck Cancer Patients, Phase III
Study Coordinator(s)V. Suzanne Klimberg, M.D., Omer Kucuk, M.D., Ehab Hanna, M.D., P.G. Shankar Giri, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists
SWOG-9430Phase II

Revision #12

A Phase II Trial of Complete Surgical Resection for Stage IV Melanoma-Surgical Resection with Biological and Clinical Follow-Up
Study Coordinator(s)Jeffrey A. Sosman, M.D., Vernon K. Sondak, M.D., James A. Warneke, M.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph J. Tuthill, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Surgeons, ECOG

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