TriangleNCT00434642 · CITED IN SOURCE DOCUMENTS
A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2017-08-09
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Overall Survival
Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)
Percentage of Patients Who Had at Least 1 Adverse Event
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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)
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
- intervention Names
- Drug: Carboplatin
- Drug: Gemcitabine
- Drug: Bevacizumab
- label
- Carboplatin and gemcitabine + bevacizumab
- type
- EXPERIMENTAL
- description
- Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
- intervention Names
- Drug: Carboplatin
- Drug: Gemcitabine
- Drug: Placebo
- label
- Carboplatin and gemcitabine + placebo
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Carboplatin and gemcitabine + bevacizumab
- Carboplatin and gemcitabine + placebo
- description
- Carboplatin was provided as commercially available drug.
- name
- Carboplatin
- type
- DRUG
- arm Group Labels
- Carboplatin and gemcitabine + bevacizumab
- Carboplatin and gemcitabine + placebo
- description
- Gemcitabine was provided as commercially available drug.
- name
- Gemcitabine
- type
- DRUG
- arm Group Labels
- Carboplatin and gemcitabine + bevacizumab
- description
- 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.
- name
- Bevacizumab
- other Names
- Avastin
- type
- DRUG
- arm Group Labels
- Carboplatin and gemcitabine + placebo
- description
- Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.
- name
- Placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 484
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- 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)
- secondary Outcomes
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- description
- Overall survival was defined as the time from randomization to death from any cause.
- measure
- Overall Survival
- time Frame
- From randomization through July 19, 2013 (up to 6 years, 3 months)
- description
- A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.
- measure
- Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)
- time Frame
- From randomization through September 17, 2010 (up to 3 years, 5 months)
- measure
- Percentage of Patients Who Had at Least 1 Adverse Event
- time Frame
- From randomization through July 19, 2013 (up to 6 years, 3 months)
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- pmid
- 37185961
- type
- DERIVED
- citation
- Aghajanian C, Goff B, Nycum LR, Wang YV, Husain A, Blank SV. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol. 2015 Oct;139(1):10-6. doi: 10.1016/j.ygyno.2015.08.004. Epub 2015 Aug 10.
- pmid
- 26271155
- type
- DERIVED
- citation
- Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.
- pmid
- 21941283
- type
- DERIVED
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