A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer
- 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
- No patients receiving other investigational therapy for the past 30 days before
- 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
- 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
- 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