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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01239732
First received: November 10, 2010
Last updated: July 1, 2015
Last verified: July 2015

November 10, 2010
July 1, 2015
December 2010
May 2015   (final data collection date for primary outcome measure)
Safety profile (incidence of adverse events) of Avastin when added to carboplatin and paclitaxel chemotherapy [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01239732 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
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

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Patients will receive 15 mg/kg Avastin intravenously 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 paclitaxel 175 mg/m2 on Day 1 every 3 weeks or 80 mg/m2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • 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
  • 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
Experimental: Single Arm
Interventions:
  • Drug: Paclitaxel
  • Drug: bevacizumab [Avastin]
  • Drug: carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1041
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Brazil,   Bulgaria,   Canada,   Denmark,   Egypt,   Estonia,   France,   Greece,   Hong Kong,   Hungary,   India,   Ireland,   Israel,   Italy,   Kuwait,   Latvia,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Uruguay
Oman,   Morocco
 
NCT01239732
MO22923, 2010-019525-34
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP