Status:
COMPLETED
Imatinib Mesylate in Combination With Docetaxel for Advanced, Platinum-Refractory Ovarian Cancer
Lead Sponsor:
Daniela Matei, MD
Collaborating Sponsors:
Novartis Pharmaceuticals
Sanofi
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Imatinib mesylate is an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events. Doc...
Detailed Description
OUTLINE: This is a multi-center study. Submit tumor and serum samples for central review * Imatinib 600 mg (orally qd); * Docetaxel 30mg/m2 (4 of 6 weeks);1 cycle = 6 weeks * Evaluate every other cy...
Eligibility Criteria
Inclusion
- Histologically documented diagnosis of ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer·
- Immunohistochemical documentation of c-Kit or PDGFR expression by tumor
- At least one measurable site of disease as defined by RECIST or evidence of disease progression by CA125 measurement
- Platinum-refractory or platinum-resistant
Exclusion
- No prior exposure to imatinib (Gleevec®) as single agent or in combination
- No chemotherapy within 28 days (42 days for nitrosourea or mitomycin-C) prior to being registered to protocol therapy.
- No prior radiotherapy to ³ 25 % of the bone marrow
- No known brain metastases.
- Negative pregnancy test
- No current breastfeeding
- No investigational agents within 28 days prior to protocol therapy
- No prior malignancy in the past 5 years unless the other primary malignancy is not currently clinically significant, nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ
- No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
- No known diagnosis of human immunodeficiency virus (HIV) infection.
- No major surgery within 28 days prior to being registered to protocol therapy.
- No refractory ascites requiring drainage more frequently than once a month
- No presence of clinically significant small bowel obstruction
- No prior exposure to docetaxel (exposure to paclitaxel is allowed)
- No parenteral nutrition within 28 days prior to being registered to protocol therapy.
- No concomitant treatment with potent CYP 3A4 inhibitors (i.e., ketoconazole) is permitted during therapy on this protocol.
- No therapeutic anticoagulation with warfarin while on study (use of low molecular weight heparin is allowed, if necessary).
- No peripheral neuropathy \> grade 1
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- No serious concomitant systemic disorders incompatible with the study
- No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin, carcinoma in-situ of the cervix, or any other cancer for which the patient has been disease-free for \< 5 years.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00216112
Start Date
December 1 2003
End Date
July 1 2007
Last Update
February 19 2016
Active Locations (9)
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1
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
2
Elkhart Clinic
Elkhart, Indiana, United States, 46515
3
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
4
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815