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

Not Recruiting

Trial ID: NCT00434642

Purpose

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.

Official Title

A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor

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)

Intervention(s):

drug: bevacizumab

drug: carboplatin

drug: gemcitabine

drug: placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sarah Charlesworth
6507960344

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