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

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Drug: bevacizumab [Avastin] Drug: carboplatin Drug: Paclitaxel	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Bevacizumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Safety profile (incidence of adverse events) of Avastin when added to carboplatin and paclitaxel chemotherapy [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Overall response rate according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Overall response rate according to Cancer antigen 125 criteria [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Duration of response according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Overall survival according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Biological progression-free survival according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	December 2010
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Arm	Drug: 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 Drug: 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 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

Arms

Assigned Interventions

Experimental: Single Arm

Drug: 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

Drug: 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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239732

Contacts

Contact: Please reference Study ID Number: MO22923 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 242 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01239732 History of Changes
Other Study ID Numbers:	MO22923, 2010-019525-34
Study First Received:	November 10, 2010
Last Updated:	May 13, 2013
Health Authority:	Serbia: Agency for Drugs and Medicinal Devices

Additional relevant MeSH terms:

Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Bevacizumab
Carboplatin

Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013