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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
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