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

NCT01164007 | Completed Phase 2 Results

• 2 other identifiers: ML187272005-003416-30
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the preliminary anti-tumor activity and safety profile of a combination of bevacizumab and dacarbazine in participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)

  Tumor assessments were performed using RECIST. CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to sum of LD at Baseline. Both were to be confirmed at a follow-up visit at least 4 weeks from the initial assessment of CR or PR. The percentage of participants with a best overall response of CR or PR during the study was reported.

  Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)

Secondary Outcomes (10)

• Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST

  Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)

• Duration of Response (DOR) With CR or PR According to RECIST

  Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)

• Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST

  Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)

• DOR With CR, PR, or SD According to RECIST

  Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)

• Percentage of Participants With Death or Disease Progression According to RECIST

  Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)

Study Arms (1)

Dacarbazine + Bevacizumab

EXPERIMENTAL

Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease will receive dacarbazine and bevacizumab until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.

Drug: Bevacizumab; Drug: Dacarbazine

Interventions

Bevacizumab DRUG

Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Days 1 and 14 of each 28-day cycle.

Also known as: Avastin

Dacarbazine + Bevacizumab

Dacarbazine DRUG

Dacarbazine will be given as 800 milligrams per square meter (mg/m\^2) via IV infusion on Day 1 of each 28-day cycle.

Dacarbazine + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed cutaneous malignant melanoma
• Clinical evidence of metastatic disease and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease
• Measurable and/or evaluable lesions according to RECIST

You may not qualify if:

• Prior interferon alfa and/or cytokine therapy for metastatic disease
• Prior chemotherapy for metastatic disease
• Brain metastases
• Chronic daily treatment with high-dose aspirin (more than 325 milligrams per day)
• Other co-existing malignancies or malignancies diagnosed within the past 5 years with the exception of basal cell cancer or cervical cancer in situ

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Istituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

Location

MeSH Terms

Conditions

Melanoma

Interventions

Bevacizumab; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 16, 2010
• Study Start: June 30, 2006
• Primary Completion: May 31, 2012
• Study Completion: May 31, 2012
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-03

Locations

IT (1)