Know Cancer

or
forgot password

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


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

Thank you

Trial Information

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


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

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 CTAE Grade >/=1 arterial thromboembolic event or Grade
>/=3 venous thromboembolic event within 6 months prior to enrolment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety profile (incidence of adverse events) of Avastin when added to carboplatin and paclitaxel chemotherapy

Outcome Time Frame:

108 weeks

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Serbia: Agency for Drugs and Medicinal Devices

Study ID:

MO22923

NCT ID:

NCT01239732

Start Date:

December 2010

Completion Date:

October 2014

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms

Name

Location