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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 6, 2009
Last updated: November 3, 2014
Last verified: November 2014

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: carboplatin
Drug: paclitaxel
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: carboplatin
iv infusion to an AUC of 6 on day 1 of each 3 week cycle
Drug: paclitaxel
80mg/m2 iv on days 1, 8 and 15 of each 3 week cycle


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

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
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Please refer to this study by its identifier: NCT00937560

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

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00937560     History of Changes
Other Study ID Numbers: MO22225, 2008-008336-85
Study First Received: July 6, 2009
Last Updated: November 3, 2014
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators processed this record on November 25, 2014