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

Trial ID or NCT#

NCT00434642

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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)
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Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc
Gynecologic oncologist
Laurie Kraus Lacob Professor
Nelson Teng

Contact us to find out if this trial is right for you.

Contact

Sarah Charlesworth
6507960344

View on ClinicalTrials.gov