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

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164007
• Other study ID #: ML18727
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2010
• Last updated: March 1, 2016
• Start date: June 2006
• Est. completion date: May 2012

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• bevacizumab [Avastin]
10 mg/kg iv, every 2 weeks
• dacarbazine
800 mg/m2 iv, every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (complete and partial responses), tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI)		4 years	No
Secondary	Safety: Adverse events, laboratory parameters		up to 4 years	No
Secondary	Duration of response; tumor assessments by CT or MRI		from response to progressive disease (up to 4 years)	No
Secondary	Time to progression; tumor assessments by CT or MRI		from baseline to disease progression or death of any cause (up to 4 years)	No
Secondary	Overall survival		from baseline to death of any cause (up to 4 years)	No