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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

From randomization through September 17, 2010

Safety Issue:

No

Principal Investigator

Amreen Husain, MD

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF4095g

NCT ID:

NCT00434642

Start Date:

April 2007

Completion Date:

October 2013

Related Keywords:

  • Ovarian Cancer
  • Avastin
  • Ovarian carcinoma
  • Peritoneal carcinoma
  • Peritoneal cancer
  • Fallopian tube cancer
  • Fallopian tube carcinoma
  • OCEANS
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms

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