Overview

This trial is active, not recruiting.

Condition ovarian cancer
Sponsor Hoffmann-La Roche
End date June 2017
Trial size 300 participants
Trial identifier NCT01863693, ML28570

Summary

This multicenter, prospective, observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. Eligible patients will be followed for approximately 15 months.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression
time frame: approximately 6 years
Safety: Incidence of adverse events
time frame: approximately 6 years

Secondary Outcomes

Measure
Overall survival, defined as time from first administration of first-line therapy to documented death
time frame: approximately 6 years
Objective response rate, defined as percentage of patients with complete or partial response according to local assessments
time frame: approximately 6 years
Quality of life: EQ-5D/EORTC questionnaires
time frame: approximately 6 years
Dosage/schedule/duration of Avastin therapy
time frame: approximately 6 years
Composition of first-line chemotherapy regimens: drugs/dosage/duration
time frame: approximately 6 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy - Initiating Avastin in combination with chemotherapy Exclusion Criteria: - Contraindications, warnings and precautions for use as specified in the Avastin Summary of Product Characteristics

Additional Information

Official title AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.