Jonathan S. Berek
A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma (OCEANS)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a placebo-controlled, randomized, multicenter Phase II study evaluating 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.
Recruiting Status:
RecruitingStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: bevacizumab
- Drug: carboplatin
- Drug: gemcitabine
- Drug: placebo
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key Exclusion Criteria:
- Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma.
- History of abdominal fistula, GIP, or intra-abdominal abscess
- Patients with clinical symptoms or signs of 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(R)) or other 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 CHF
- History of myocardial infarction or unstable angina
- History of stroke or transient ischemic attack (TIA)
- Known 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)
Additional Study Details
Official Title:
A Phase II, Multicenter, Randomized, Blinded, Placebo-Controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-Sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube CarcinomaAnticipated start date:
4/25/2008Lead Sponsor:
GenentechInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Progression-free survival
Secondary Outcomes:
- Objective response and duration of response
- Overall survival
- Incidence of gastrointestinal perforation (GIP)
- Characterization of the safety of bevacizumab in combination with carboplatin and gemcitabine
- Incidence of all adverse events
Total Number to be Enrolled:
450Total Number to be Enrolled at Stanford:
24More Information
Secondary ID(s):
- 97978
- AVF4095g
- GYNOPF0004
- NCT00434642
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
9/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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