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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01164007
First received: July 8, 2010
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This study will assess the preliminary antitumor activity and safety profile of a combination of Avastin and dacarbazine in patients with unresectable/metastati c melanoma not previously treated with chemotherapy for metastatic disease. Pati ents will receive Avastin 10mg/kg iv every 2 weeks and dacarbazine 800mg/m2 ever y 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Adverse events, laboratory parameters [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Duration of response; tumor assessments by CT or MRI [ Time Frame: from response to progressive disease (up to 4 years) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: from baseline to death of any cause (up to 4 years) ] [ Designated as safety issue: No ]

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01164007

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01164007     History of Changes
Other Study ID Numbers: ML18727
Study First Received: July 8, 2010
Last Updated: October 6, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on October 29, 2014