A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00937560
First received: July 6, 2009
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This single arm study will evaluate the efficacy and safety of first line chemot herapy with carboplatin and dose-dense weekly paclitaxel plus Avastin in patient s with epithelial ovarian, fallopian tube or primary peritoneal cancer. patients will receive 6 to 9 x 3-week cycles of treatment with Avastin (7.5mg/kg iv on d ay 1 of each cycle), paclitaxel (80mg/m2 iv on days 1, 8 and 15 of each cycle) a nd carboplatin (iv to an AUC of 6 on day 1 of each cycle).Following combination chemotherapy, Avastin may continue to be given as monotherapy. The anticipated t ime on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Ovarian Cancer
Drug: bevacizumab [Avastin]
Drug: paclitaxel
Drug: carboplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: assessed after cycles 3,6 and 9 of triple treatment and every 18 weeks on maintenance monotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate, duration of response, overall survival, biological progression-free interval [ Time Frame: assessed after cycles 3,6 and 9 of triple treatment and every 18 weeks on maintenance monotherapy ] [ Designated as safety issue: No ]
  • Adverse events, cardiac events, lab parameters, ECOG performance status, vital signs [ Time Frame: Throughout study, laboratory and EOCG assessments every 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: June 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle
Drug: paclitaxel
80mg/m2 iv on days 1, 8 and 15 of each 3 week cycle
Drug: carboplatin
iv infusion to an AUC of 6 on day 1 of each 3 week cycle

  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;
  • epithelial ovarian, fallopian tube or primary peritoneal cancer;
  • initial surgery, but no chemotherapy or radiotherapy;
  • ECOG performance status of 0-2.

Exclusion Criteria:

  • non-epithelial tumors;
  • ovarian tumors with low malignant potential;
  • previous systemic anti-cancer therapy for ovarian cancer;
  • history or evidence of synchronous primary endometrial cancer;
  • current or recent daily treatment with aspirin (>325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.
  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: NCT00937560

  Show 55 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00937560     History of Changes
Other Study ID Numbers: MO22225, 2008-008336-85
Study First Received: July 6, 2009
Last Updated: July 7, 2014
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Ovarian 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
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 22, 2014