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

Summary

The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.

Eligibility

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

Conditions2

Locations1 site

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