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Completed

NCT Number: NCT00434642

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

carboplatin

Drug

Carboplatin was provided as commercially available drug.

Gemcitabine

Drug

Gemcitabine was provided as commercially available drug.

Bevacizumab

Drug

Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL [25 mg/mL]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Other names: Avastin

Placebo

Drug

Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Primary outcomes

  1. Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)

    Time frame: From randomization through September 17, 2010 (up to 3 years, 5 months)

    PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.

Secondary outcomes

  1. Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)

    Time frame: From randomization through September 17, 2010 (up to 3 years, 5 months)

    An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.

  2. Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)

    Time frame: From randomization through September 17, 2010 (up to 3 years, 5 months)

    Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.

  3. Overall Survival

    Time frame: From randomization through July 19, 2013 (up to 6 years, 3 months)

    Overall survival was defined as the time from randomization to death from any cause.

  4. Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)

    Time frame: From randomization through September 17, 2010 (up to 3 years, 5 months)

    A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.

  5. Percentage of Patients Who Had at Least 1 Adverse Event

    Time frame: From randomization through July 19, 2013 (up to 6 years, 3 months)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Acronym: OCEANS

Important dates

Study start
2007
Primary completion
2010
Study completion
2013
First posted
Feb 13, 2007
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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