Clinical trial NCT01164007: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Secondary outcomes:
measure: Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: Duration of Response (DOR) With CR or PR According to RECIST
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: DOR With CR, PR, or SD According to RECIST
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: Percentage of Participants With Death or Disease Progression According to RECIST
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: Time to Progression (TTP) According to RECIST
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: Percentage of Participants Who Discontinued Treatment
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: Time to Treatment Failure (TTF)
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: Percentage of Participants Who Died
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
measure: Overall Survival (OS)
timeFrame: Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: