Back to resultsA Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
Primary Purpose
Malignant Melanoma
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Bevacizumab
Dacarbazine
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Melanoma
Eligibility Criteria
Inclusion Criteria:
- 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
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 (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
Sites / Locations
- Istituto Europeo Di Oncologia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dacarbazine + Bevacizumab
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST
Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR or PR was reported.
Duration of Response (DOR) With CR or PR According to RECIST
Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR or PR to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. DOR was estimated by Kaplan-Meier methodology and expressed in months.
Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST
Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR, PR, or SD was reported.
DOR With CR, PR, or SD According to RECIST
Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR, PR, or SD to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. DOR was estimated by Kaplan-Meier methodology and expressed in months.
Percentage of Participants With Death or Disease Progression According to RECIST
Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). The percentage of participants who died or demonstrated disease progression was reported.
Time to Progression (TTP) According to RECIST
Tumor assessments were performed using RECIST. TTP was defined as the time from Baseline visit to time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTP was estimated by Kaplan-Meier methodology and expressed in months.
Percentage of Participants Who Discontinued Treatment
The percentage of participants who discontinued treatment as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
Time to Treatment Failure (TTF)
TTF was defined as the time from start of treatment to the time of treatment discontinuation as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTF was estimated by Kaplan-Meier methodology and expressed in months.
Percentage of Participants Who Died
The percentage of participants who died from any cause was reported.
Overall Survival (OS)
OS was defined as the time from Baseline visit to the time of death from any cause. OS was estimated by Kaplan-Meier methodology and expressed in months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01164007
Brief Title
A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
Official Title
Phase II Study of Dacarbazine With the Anti-Vascular Endothelial Growth Factor Antibody (Bevacizumab) in Patients With Unresectable/Metastatic Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 30, 2006 (Actual)
Primary Completion Date
May 31, 2012 (Actual)
Study Completion Date
May 31, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dacarbazine + Bevacizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Description
Dacarbazine will be given as 800 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 28-day cycle.
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Description
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.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST
Description
Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR or PR was reported.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
Duration of Response (DOR) With CR or PR According to RECIST
Description
Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR or PR to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. DOR was estimated by Kaplan-Meier methodology and expressed in months.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST
Description
Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR, PR, or SD was reported.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
DOR With CR, PR, or SD According to RECIST
Description
Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR, PR, or SD to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. DOR was estimated by Kaplan-Meier methodology and expressed in months.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
Percentage of Participants With Death or Disease Progression According to RECIST
Description
Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). The percentage of participants who died or demonstrated disease progression was reported.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
Time to Progression (TTP) According to RECIST
Description
Tumor assessments were performed using RECIST. TTP was defined as the time from Baseline visit to time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTP was estimated by Kaplan-Meier methodology and expressed in months.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
Percentage of Participants Who Discontinued Treatment
Description
The percentage of participants who discontinued treatment as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
Time to Treatment Failure (TTF)
Description
TTF was defined as the time from start of treatment to the time of treatment discontinuation as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTF was estimated by Kaplan-Meier methodology and expressed in months.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
Percentage of Participants Who Died
Description
The percentage of participants who died from any cause was reported.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Title
Overall Survival (OS)
Description
OS was defined as the time from Baseline visit to the time of death from any cause. OS was estimated by Kaplan-Meier methodology and expressed in months.
Time Frame
Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
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