Trial Search Results

A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma

This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Genentech, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Carboplatin
  • Drug: Gemcitabine
  • Drug: Bevacizumab
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Signed Informed Consent Form

   - Age ≥ 18 years

   - Documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred

   - No prior chemotherapy in the recurrent setting

   - Measurable disease

   - Recovered from prior radiation therapy or surgery

Exclusion Criteria:

   - Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian
   tube carcinoma

   - History of abdominal fistula, gastrointestinal perforation (GIP), or intra-abdominal
   abscess

   - Patients with clinical symptoms or signs of gastrointestinal (GI) obstruction or who
   require parenteral hydration, parenteral nutrition, or tube feeding

   - Patients with evidence of abdominal free air not explained by paracentesis or recent
   surgical procedure

   - Current, recent, or planned participation in an experimental drug study

   - History of systemic bevacizumab (Avastin) or other vascular endothelial growth factor
   (VEGF) or VEGF receptor-targeted agent use

   - Inadequately controlled hypertension

   - Prior history of hypertensive crisis or hypertensive encephalopathy

   - New York Heart Association Class II or greater congestive heart failure (CHF)

   - History of myocardial infarction or unstable angina

   - History of stroke or transient ischemic attack (TIA)

   - Known central nervous system (CNS) disease except for treated brain metastasis

   - Significant vascular disease or recent peripheral arterial thrombosis

   - History of hemoptysis

   - Evidence of bleeding diathesis or significant coagulopathy (in the absence of
   therapeutic anticoagulation)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sarah Charlesworth
6507960344
Not Recruiting