A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
- Registration Number
- NCT01164007
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dacarbazine + Bevacizumab Bevacizumab 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. Dacarbazine + Bevacizumab Dacarbazine 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months) 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
Name Time Method 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) 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 to Treatment Failure (TTF) Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months) 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.
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) 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 Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months) 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 to Progression (TTP) According to RECIST Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months) 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 Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months) 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).
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) 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 Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months) 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.
Percentage of Participants Who Died Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months) The percentage of participants who died from any cause was reported.
Overall Survival (OS) Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months) 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.
Trial Locations
- Locations (1)
Istituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy