A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian Cancer

Inclusion Criteria:

* Patients aged \> 18
* Histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and uterine papillary serous carcinomas (UPSC), and gynecologic malignant mixed müllerian tumors (MMMTs).
* Must have had prior platinum or platinum based therapy.
* Eastern Cooperative Oncology Group (ECOG) status 0-1.
* Platinum resistant or refractory disease within 6 months of completing or while receiving a platinum and taxane containing regimen
* Measurable disease
* Adequate bone marrow and hematological function.
* Must have recovered from acute toxicity from prior treatment
* Prior treatment with an anti-angiogenic agent is not an exclusion criterion.
* No prior GI perforation, or GI obstruction or involvement of the bowel on imaging
* Known hypersensitivity to Cremophor EL. However, participants are eligible if they have had a prior paclitaxel reaction, but subsequently tolerated the drug at rechallenge.
* No patients receiving other investigational therapy for the past 30 days before dosing.

Exclusion Criteria:

* More than 3 prior lines of chemotherapy for recurrent cancer.
* History of other active malignancy, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix within last 2 years.
* Life expectancy of less than 3 months
* CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes.
* Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy.
* New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction or unstable angina within 6 months prior to study Day 1.
* History of stroke or transient ischemic attack within 6 months prior to Day 1.
* Known CNS disease, except for treated brain metastasis
* Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1.
* History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1.
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).