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


Tracking Information

Start Date  ICMJEJune 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: July 10, 2009)		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 ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00937560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 10, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
Official Title  ICMJE 
Brief Summary

This single arm study will evaluate the efficacy and safety of first line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus Avastin in patients 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 day 1 of each cycle), paclitaxel (80mg/m2 iv on days 1, 8 and 15 of each cycle) and 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 time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEOvarian Cancer
Intervention  ICMJE
  • 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
Study Arms / Comparison Groups1: Experimental
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: paclitaxel
  • Drug: carboplatin

Recruitment Information

Estimated Enrollment  ICMJE180
Estimated Completion DateMay 2012
Primary Completion Date 
Eligibility Criteria  ICMJE

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.
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: MO22225888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEBrazil,   France,   Italy,   Netherlands,   Norway,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00937560
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEMO22225, 2008-008336-85
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche