ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, cancer, ovary, carboplatin, paclitaxel, VS-6063, primary peritoneal carcinoma, fallopian tube, defactinib Read More

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