Imatinib Mesylate in Combination With Docetaxel for Advanced, Platinum-Refractory Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Medical & Surgical Specialists, LLC
- Elkhart Clinic
- Oncology Hematology Associates of SW Indiana
- Fort Wayne Oncology & Hematology, Inc
- Indiana University Cancer Center
- Arnett Cancer Care
- Medical Consultants, P.C.
- Center for Cancer Care, Inc., P.C.
- AP&S Clinic
Arms of the Study
Arm 1
Experimental
Investigational Treatment
Imatinib Mesylate + Docetaxel