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 prof ile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitax el therapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Patients will receive 15 mg/kg Avastin intraven ously 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 paclitax el 175 mg/m2 on Day 1 every 3 weeks or 80 mg/m2 every week for a maximum of 8 cy cles. The anticipated time on study drug will be 108 weeks or until disease prog ression 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

Genetic and Rare Diseases Information Center resources: Fallopian Tube Cancer Ovarian Cancer Ovarian Epithelial Cancer

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 ]


Enrollment:	1041
Study Start Date:	December 2010
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 241 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:	January 26, 2015
Health Authority:	Serbia: Agency for Drugs and Medicinal Devices

Additional relevant MeSH terms:


Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Neoplasms	Bevacizumab Carboplatin Angiogenesis Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents Growth Inhibitors Growth Substances Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015