A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01069627
First received: December 15, 2009
Last updated: May 23, 2014
Last verified: May 2014
Results First Received: May 23, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Interventions: Drug: bevacizumab [Avastin]
Drug: fotemustine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bevacizumab + Fotemustine

Cycle 1 (3-week cycle): Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 and fotemustine 100 mg per square meter (mg/m^2) IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.

Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.

Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.

Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity.


Participant Flow:   Overall Study
    Bevacizumab + Fotemustine  
STARTED     20  
COMPLETED     0  
NOT COMPLETED     20  
Disease progression                 7  
Adverse Event                 12  
Protocol Violation                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: all participants who signed the informed consent form, were assigned a study patient number, and took at least one dose of each drug of study combination.

Reporting Groups
  Description
Bevacizumab + Fotemustine

Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.

Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.

Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.

Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity.


Baseline Measures
    Bevacizumab + Fotemustine  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Mean ± Standard Deviation
  51  ± 15  
Gender  
[units: participants]
 
Female     8  
Male     12  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Complete Response (CR) or Partial Response (PR)   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

2.  Primary:   Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

3.  Secondary:   Time to Progression (TTP) - Percentage of Participants With an Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

4.  Secondary:   TTP - Time to Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

5.  Secondary:   Duration of CR - Percentage of Participants With an Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

6.  Secondary:   Duration of CR - Time to Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

7.  Secondary:   Duration of Overall Response of CR or PR - Percentage of Participants With an Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

8.  Secondary:   Duration of Overall Response of CR or PR - Time to Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

9.  Secondary:   Duration of Stable Disease - Percentage of Participants With an Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

10.  Secondary:   Duration of Stable Disease - Time to Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

11.  Secondary:   Overall Survival (OS) - Percentage of Participants With an Event   [ Time Frame: Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months) ]

12.  Secondary:   OS - Time to Event   [ Time Frame: Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months) ]

13.  Secondary:   Time to Treatment Failure (TTF) - Percentage of Participants With an Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

14.  Secondary:   TTF - Time to Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

15.  Secondary:   Time to CR - Percentage of Participants With an Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

16.  Secondary:   Time to CR - Time To Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

17.  Secondary:   Time to Overall Response of CR or PR - Percentage of Participants With an Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]

18.  Secondary:   Time to Overall Response of CR or PR - Time to Event   [ Time Frame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01069627     History of Changes
Other Study ID Numbers: ML19309
Study First Received: December 15, 2009
Results First Received: May 23, 2014
Last Updated: May 23, 2014
Health Authority: Italy: Ministero della Salute