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Clinical Trials/EUCTR2010-019525-34-SE
EUCTR2010-019525-34-SEActive, not recruitingNot Applicable

GLOBAL STUDY TO ASSESS THE ADDITION OF BEVACIZUMAB TO CARBOPLATIN AND PACLITAXEL AS FRONT-LINE TREATMENT OF EPITHELIAL OVARIAN CANCER, FALLOPIAN TUBE CARCINOMA OR PRIMARY PERITONEAL CARCINOMA - ROSiA

F. Hoffmann-La Roche Ltd0 sites1,000 target enrollmentStarted: October 29, 2010Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,000
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • •- Female patients, >/=18 years of age
  • •- Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Patients with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
  • •- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
  • •- Life expectancy >/=3 months
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 610
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 390

Exclusion Criteria

  • •- Patients with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e. borderline tumors), or synchronous primary endometrial carcinoma
  • •- Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
  • •- Planned intraperitoneal cytotoxic chemotherapy
  • •- Radiotherapy within 28 days of Day 1, Cycle 1
  • •- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
  • •- History or evidence of NCI CTCAE Grade =1 arterial thromboembolic event or Grade =3 venous thromboembolic event within the 6 months prior to enrolment

Investigators

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