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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01239732
First received: November 10, 2010
Last updated: July 28, 2014
Last verified: July 2014
  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:


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: August 2014
Estimated Primary Completion Date: August 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

  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

Contacts
Contact: Reference Study ID Number: MO22923 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  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: July 28, 2014
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 July 28, 2014