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A Study of Avastin (Bevacizumab) in Combination With Dacarbazine in Patients With Unresectable/Metastatic Melanoma.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 8, 2010
Last updated: March 1, 2016
Last verified: March 2016
This study will assess the preliminary antitumor activity and safety profile of a combination of Avastin and dacarbazine in patients with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease. Patients will receive Avastin 10mg/kg iv every 2 weeks and dacarbazine 800mg/m2 every 4 weeks. The anticipated time on study treatment is until disease progression.

Condition Intervention Phase
Malignant Melanoma
Drug: bevacizumab [Avastin]
Drug: dacarbazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Determine the Effect of Avastin in Combination With Dacarbazine on Overall Response Rate in Patients With Unresectable/Metastatic Melanoma

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall response rate (complete and partial responses), tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI) [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Safety: Adverse events, laboratory parameters [ Time Frame: up to 4 years ]
  • Duration of response; tumor assessments by CT or MRI [ Time Frame: from response to progressive disease (up to 4 years) ]
  • Time to progression; tumor assessments by CT or MRI [ Time Frame: from baseline to disease progression or death of any cause (up to 4 years) ]
  • Overall survival [ Time Frame: from baseline to death of any cause (up to 4 years) ]

Enrollment: 37
Study Start Date: June 2006
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
10 mg/kg iv, every 2 weeks
Drug: dacarbazine
800 mg/m2 iv, every 4 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • cutaneous malignant melanoma;
  • clinical evidence of metastatic disease and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease;
  • measurable lesions.

Exclusion Criteria:

  • prior interferon alfa and/or cytokine therapy for metastatic disease;
  • prior chemotherapy for metastatic disease;
  • brain metastases;
  • chronic daily treatment with high dose aspirin (>325mg/day);
  • other coexisting malignancies, or malignancies diagnosed within the past 5 years, other then basal cell cancer or cervical cancer in situ.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01164007

Milano, Lombardia, Italy, 20141
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01164007     History of Changes
Other Study ID Numbers: ML18727
Study First Received: July 8, 2010
Last Updated: March 1, 2016

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on March 23, 2017