Imatinib Mesylate in Combination With Docetaxel for Advanced, Platinum-Refractory Ovarian Cancer

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.