A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239732
• Other study ID #: MO22923
• Secondary ID: 2010-019525-34
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2010
• Last updated: February 1, 2016
• Start date: December 2010
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial Summary

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Patients will receive 15 mg/kg Avastin intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (AUC 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 mg/m2 on Day 1 every 3 weeks or 80 mg/m2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1041
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Paclitaxel
175 mg/m2 on Day 1 every 3 weeks or at a dose of 80 mg/m2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
• bevacizumab [Avastin]
15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first
• carboplatin
AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Austria,  Brazil,  Bulgaria,  Canada,  Denmark,  Egypt,  Estonia,  France,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Kuwait,  Latvia,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile (incidence of adverse events) of Avastin when added to carboplatin and paclitaxel chemotherapy		108 weeks	No
Secondary	Progression-free survival according to Response evaluation criteria in solid tumors (RECIST)		108 weeks	No
Secondary	Overall response rate according to Response evaluation criteria in solid tumors (RECIST)		108 weeks	No
Secondary	Overall response rate according to Cancer antigen 125 criteria		108 weeks	No
Secondary	Duration of response according to Response evaluation criteria in solid tumors (RECIST)		108 weeks	No
Secondary	Overall survival according to Response evaluation criteria in solid tumors (RECIST)		108 weeks	No
Secondary	Biological progression-free survival according to Response evaluation criteria in solid tumors (RECIST)		108 weeks	No