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
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Drug: bevacizumab [Avastin]
Drug: fotemustine
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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: From study start through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069627

Locations
Italy
Firenze, Italy, 50100
Genova, Italy, 16132
Milano, Italy, 20133
Torino, Italy, 10126
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Last Updated: January 18, 2011
Health Authority: Italy: Ministero della Salute

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Fotemustine
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014