NCT01131039
Withdrawn
Phase 2
A Phase II Trial of Gemcitabine Plus Bevacizumab in Patients With Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer
InterventionsGemcitabine/Bevacizumab
Overview
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Emory University
- Primary Endpoint
- Progression-free survival
Overview
Brief Summary
The purpose of the study is to determine whether the administration of bevacizumab and gemcitabine given by IV infusion can prolong survival, delay tumor growth, and/or shrink tumors in patients with ovarian cancer, primary peritoneal, or fallopian tube cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have platinum-resistant ovarian, primary peritoneal or fallopian tube cancer.
- •Patients will be included in the study based on the following criteria:
- •Signed informed consent
- •Age ≥ 19 yrs
- •Advanced, histologically documented ovarian, primary peritoneal, or fallopian tube cancer
- •Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded). Each lesion must be \> 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT and MRI, or \> 10 mm when measured by spiral CT. OR Clinically or radiologically detectable disease (ascites, peritoneal deposits, mesenteric thickening or lesions that do not fulfill RECIST for measurable disease). In addition, the subject must have two consecutive rising pretreatment CA-125 levels that are both \> 2x the institutional upper limit of normal (ULN) and 40.0 IU/ml taken at least 1 week and nor more than 3 months apart.
- •Platinum-resistant or refractory cancer; subjects must not have had a biologic or chemotherapeutic regimen for treatment of platinum-resistant disease prior to study entry. Subjects with primary platinum-resistant cancer must have had a tumor recurrence within 6 months after completing or while receiving a platinum-containing regimen. These subjects must not have had any other non-platinum-containing regimen. OR Subjects with secondary platinum-resistant cancer may have had any regimen with any response and then have had tumor recurrence within 6 months after completing or while receiving retreatment with a platinum-containing regimen. These subjects must have received only two prior chemotherapeutic regimens. OR Subjects who receive a chemotherapeutic regimen as consolidation after a response to a platinum-containing regimen must have had tumor recurrence within 6 months after completing or while receiving the consolidation regimen.
- •Life expectancy \> 12 weeks
- •ECOG performance status 0 or 1
- •Use of an effective means of contraception (for women of childbearing potential)
Exclusion Criteria
- •Prior treatment with gemcitabine
- •Three or more prior chemotherapeutic regimens for the management of primary disease
- •Prior treatment with experimental anti-cancer agents within 4 weeks prior to Day 1 (the day the first study treatment infusions are administered)
- •History or clinical evidence of central nervous system or brain metastases
- •Prior treatment with Avastin or other anti-angiogenic agent
- •Uncontrolled hypercalcemia ( \>11.5 mg/dL)
- •History of other malignancies within 5 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, basal or squamous cell skin cancer
- •History of serious systemic disease, unstable angina, myocardial infarction, stroke, transient ischemic attack,, symptoms of CHF, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, are eligible) within 6 months prior to Day 1 of treatment
- •Known HIV infection
- •Pregnancy or lactation
Arms & Interventions
Single
Experimental
Intervention: Gemcitabine/Bevacizumab (Drug)
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 2 years
The primary outcome measure is progression-free survival. Disease status and response rates will be determined by investigator assessment using RECIST or CA-125 changes (subjects with nonmeasurable disease only)
Secondary Outcomes
- Safety and tolerability of bevacizumab in combination with gemcitabine will be assessed.(2 years)
Investigators
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