Priority Lists
Protocol Posting of
Activations
Activation
A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer
| Action Codes | ER |
| Study Coordinator(s) | Gregory P. Swanson, M.D. |
| Participants | CTSU |
Closures
Permanent closure effective January 1, 2007
Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
| Study Coordinator(s) | Philip Gold, M.D. |
| Participants | Members, NCORP |
| Closure Date | 2007-01-01 |
Permanent Closure
Phase II Trial of Combination Thalidomide plus Temozolomide in Patients with Metastatic Melanoma
| Study Coordinator(s) | Joseph I. Clark, M.D., Laura F. Hutchins, M.D., Jeffrey A. Sosman, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
| Closure Date | 2007-01-01 |
Permanent Closure effective 1-1-08.
Phase II Evaluation of E7389 (NSC-707389) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
| Study Coordinator(s) | Susanne M. Arnold, M.D. |
| Participants | Members, NCORP, Affiliates |
| Closure Date | 2008-01-01 |
Amendments, Revisions, Memoranda
Memorandum
A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571)(NSC # 716051,IND # 61135), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG
| Study Coordinator(s) | Margaret R. O'Donnell, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Revision #1
A Phase II Study to Evaluate the Safety and Efficacy of Zevalin® (IND # BB IND 11023)Therapeutic Regimen in Patients With Transformed CD20+ B-Cell Non-Hodgkin's Lymphoma
| Study Coordinator(s) | Fay Young, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists |
Revision #5
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. |
| Participants | Limited: Institutions Listed on the Title Page |
Amendment #4 & Revision #7
A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
| Study Coordinator(s) | Oliver W. Press, M.D.,Ph.D., David G. Maloney, M.D.,Ph.D., Rita M. Braziel, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, CTSU |
Memorandum
A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
| Action Codes | NR |
| Study Coordinator(s) | Stephen H. Petersdorf, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU |
Amendment #2
A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasma Proliferative Disorders
| Action Codes | IP, AC, FBR |
| Study Coordinator(s) | Madhav V. Dhodapkar, M.D., Bart Barlogie, M.D.,Ph.D., John D. Shaughnessy, Jr., Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Amendment #2 and Memorandum
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. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
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 Codes | NR |
| 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 |
| Participants | Members, NCORP, Medical Oncologists, CTSU |
Revision #6
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
| Study Coordinator(s) | Halle C.F. Moore, M.D., Silvana Martino, D.O. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CALGB, ECOG, IBCSG |
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. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Revision #3
A Phase II Surgical Trial of Intralesional Resection of Low-Grade Intracompartmental Chondrosarcoma of Bone
| Study Coordinator(s) | R. Lor Randall, M.D., J. Sybil Biermann, M.D., Edward Y. Cheng, M.D., Julia Crim, M.D., Lester Layfield, M.D., Joseph Buckwalter, M.D., James Martin, M.D., George Demetri, M.D., Margaret von Mehren, M.D., Vivien Bramwell, M.D.,Ph.D. |
| Participants | Intergroup Coalition Against Sarcomas Members, Members, NCORP, Surgeons, ACOSOG |
Revision #2
Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates
| Action Codes | IP, ER |
| Study Coordinator(s) | Lawrence P. Leichman, M.D., Charles R. Thomas Jr., M.D., Kevin G. Billingsley, M.D., Thomas J. Watson, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons |
Memorandum
Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
| Study Coordinator(s) | Charles R. Thomas Jr., M.D., Charles D. Blanke, M.D., James L. Abbruzzese, M.D., Lisa Hammond, M.D., Vivek Mehta, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons |
Memorandum
Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
| Study Coordinator(s) | Philip Gold, M.D. |
| Participants | Members, NCORP |
Revision #3
Phase II Trial of Pemetrexed for Advanced Chondrosarcomas
| Study Coordinator(s) | Warren Chow, M.D., John Goldblum, M.D., Diane L. Persons, M.D., Ernest C. Borden, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D. |
| Participants | Intergroup Coalition Against Sarcomas Members in the United States, Members, NCORP, Surgeons, Pathologists, CTSU Institutions in the United States |
Memorandum
A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Yuhchyau Chen, M.D., Ph.D, Kishan J. Pandya, M.D., Karen Kelly, M.D., Derick H.M. Lau, M.D.,Ph.D., Laurie E. Gaspar, M.D., Fred R. Hirsch, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists |
Amendment #2
Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
| Study Coordinator(s) | Margaret von Mehren, M.D., John Goldblum, M.D., George Demetri, M.D., Vivien Bramwell, M.D.,Ph.D. |
| Participants | Intergroup Coalition Against Sarcomas Members, Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum
A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
| Action Codes | ER |
| Study Coordinator(s) | Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
| Study Coordinator(s) | Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
| Study Coordinator(s) | Mark H. Kirschbaum, M.D., Jasmine M. Zain, M.D., Lisa M. Rimsza, M.D., Raymond R. Tubbs, D.O. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #2 & Memorandum
Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
| Study Coordinator(s) | Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Antoinette J. Wozniak, M.D., Charles R. Thomas Jr., M.D., Karen Kelly, M.D., Laurie E. Gaspar, M.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
2 Memoranda - safety reports for bevacizumab and cetuximab
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #11
L-Selenium-Based Chemoprevention of Prostate Cancer Among Men with High Grade Prostatic Intraepithelial Neoplasia
| Study Coordinator(s) | James R. Marshall, Ph.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D., E. David Crawford, M.D., Ian M. Thompson Jr., M.D., Donna L. Berry, R.N.,Ph.D. |
| Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, VA Special Member Institutions |
Amendment #15
Lung Cancer Specimen Repository Protocol, Ancillary
| Action Codes | ER |
| Study Coordinator(s) | Wilbur A. Franklin, M.D., Paul H. Gumerlock, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU, NCIC-CTG, 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