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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041041 |
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have persistent or recurrent ovarian epithelial or primary peritoneal cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Evaluation Of Gleevec (Imatinib Mesylate) (IND #61135, NSC #716051) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma |
Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 4-15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
At least 1 unidimensionally measurable target lesion
At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Women's Cancer Center at Community Hospital of Los Gatos | |
Los Gatos, California, United States, 95032 | |
United States, Illinois | |
MBCCOP - University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103-1489 | |
United States, New York | |
Long Island Cancer Center at Stony Brook University Hospital | |
Stony Brook, New York, United States, 11790-7775 | |
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1065 | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44124 | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106 | |
United States, Oklahoma | |
University of Oklahoma College of Medicine | |
Oklahoma City, Oklahoma, United States, 73190 | |
United States, Pennsylvania | |
Abington Memorial Hospital | |
Abington, Pennsylvania, United States, 19001-3788 | |
Abramson Cancer Center at University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033-0850 | |
United States, Vermont | |
Fletcher Allen Health Care - Medical Center Campus | |
Burlington, Vermont, United States, 05401 | |
United States, Washington | |
Tacoma General Hospital | |
Tacoma, Washington, United States, 98405 |
Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000069438, GOG-0170E |
Study First Received: | July 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00041041 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms |
Recurrence Carcinoma Imatinib Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Adnexal Diseases |