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: January 18, 2011
Last verified: January 2011

December 15, 2009
January 18, 2011
Not Provided
April 2010   (final data collection date for primary outcome measure)
Overall response rate (ORR) [ Time Frame: From study start through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01069627 on ClinicalTrials.gov Archive Site
  • Time to progression (TTP) [ Time Frame: From start of treatment to the onset of disease progression, or death, or the last date the patient was known to be progression-free or alive ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: From the day of response evidence to the day of disease progression ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From start of treatment up to death or the last date the patient was known to be alive ] [ Designated as safety issue: No ]
  • Time to treatment failure (TTF) [ Time Frame: From start of treatment to evidence of treatment failure ] [ Designated as safety issue: No ]
  • Frequency of adverse events (AEs) [ Time Frame: From study start through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma
An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma

This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: bevacizumab [Avastin]
    15 mg/kg intravenously on day 1 of every 3 week cycle
  • Drug: fotemustine
    100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: fotemustine
Del Vecchio M, Mortarini R, Canova S, Di Guardo L, Pimpinelli N, Sertoli MR, Bedognetti D, Queirolo P, Morosini P, Perrone T, Bajetta E, Anichini A. Bevacizumab plus fotemustine as first-line treatment in metastatic melanoma patients: clinical activity and modulation of angiogenesis and lymphangiogenesis factors. Clin Cancer Res. 2010 Dec 1;16(23):5862-72. Epub 2010 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • cutaneous malignant melanoma;
  • advanced, inoperable stage IV melanoma;
  • measurable and/or evaluable sites of metastases.

Exclusion Criteria:

  • prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;
  • prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;
  • clinically significant cardiovascular disease;
  • ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01069627
ML19309
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2011

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