Inclusion Criteria:
- Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal
carcinoma, diagnosed within 6 months of completing their most recent
platinum-containing chemotherapy.
- Patients with the following histologic cell types are eligible: Serous adenocarcinoma,
endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma,
clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma,
malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
- Must have had one prior platinum-based chemotherapeutic regimen for management of
primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
This initial treatment may have included intraperitoneal therapy, high-dose therapy,
consolidation, noncytotoxic agents or extended therapy administered after surgical or
non-surgical assessment.
- Must have NOT received more than two total prior lines of cytotoxic chemotherapy for
management of recurrent or persistent disease, including retreatment with initial
chemotherapy regimens.
- May have received one additional non-cytotoxic regimen for management of recurrent or
persistent disease according to the following definition: Non-cytotoxic (biologic or
cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies,
cytokines, and small molecule inhibitors of signal transduction.
- Women of childbearing potential must have a negative serum pregnancy test prior to
study entry and be practicing an effective form of contraception.
Must have adequate:
- Bone marrow function
- Renal function
- Hepatic function
- Neurologic function
- Recovered from effects of recent surgery, radiotherapy, or chemotherapy. All
persistent clinically significant toxicities from prior chemotherapy must be less than
or equal to Grade 1.
- Free of active infection requiring antibiotics (with the exception of uncomplicated
UTI).
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one
week prior to registration.
Exclusion Criteria:
- Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma.
- Known second primary or prior malignancy diagnosed within 5 years of study start date
(other than previously treated non-melanoma skin cancer).
- Current treatment with chemotherapy or radiation therapy. Any prior therapy directed
at the malignant tumor, including biologic and immunologic agents, must be
discontinued at least three weeks prior to registration.
- History of treatment with known kinase inhibiting agents.
- History of gastrointestinal fistula, hemorrhage, perforation or peptic ulcer disease.
- Patients who are pregnant or breastfeeding
