Status:

COMPLETED

A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian,...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Female patients, ≥ 18 years of age.
  • Epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Initial surgery, but no chemotherapy or radiotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Exclusion Criteria
  • Non-epithelial tumors.
  • Ovarian tumors with low malignant potential.
  • Previous systemic anti-cancer therapy for ovarian cancer.
  • History or evidence of synchronous primary endometrial cancer.
  • Current or recent daily treatment with aspirin (\> 325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.

Exclusion

    Key Trial Info

    Start Date :

    June 25 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2013

    Estimated Enrollment :

    190 Patients enrolled

    Trial Details

    Trial ID

    NCT00937560

    Start Date

    June 25 2009

    End Date

    July 1 2013

    Last Update

    November 6 2017

    Active Locations (55)

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    Page 1 of 14 (55 locations)

    1

    Hospital Amaral Carvalho

    Jaú, São Paulo, Brazil, 17210-080

    2

    Hospital das Clinicas - FMUSP, Oncologia

    São Paulo, São Paulo, Brazil, 05403-000

    3

    Centre Hospitalier Henri Duffaut; Hematologie

    Avignon, France, 84902

    4

    Clinique Tivoli; Sce Radiotherapie

    Bordeaux, France, 33000