Clinical trial NCT01069627: A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma
Official title: An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 20
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 investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously\[IV\]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* cutaneous malignant melanoma;
* advanced, inoperable stage IV melanoma;
* measurable and/or evaluable sites of metastases.

Exclusion Criteria:

* prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;
* prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;
* clinically significant cardiovascular disease;
* ongoing treatment with aspirin (\>325mg/day) or other medications known to predispose to gastrointestinal ulceration.

Primary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
Secondary outcomes:
measure: Time to Progression (TTP) - Percentage of Participants With an Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: TTP - Time to Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Duration of CR - Percentage of Participants With an Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Duration of CR - Time to Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Duration of Overall Response of CR or PR - Percentage of Participants With an Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Duration of Overall Response of CR or PR - Time to Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Duration of Stable Disease - Percentage of Participants With an Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Duration of Stable Disease - Time to Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)
measure: OS - Time to Event
timeFrame: Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)
measure: Time to Treatment Failure (TTF) - Percentage of Participants With an Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: TTF - Time to Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Time to CR - Percentage of Participants With an Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Time to CR - Time To Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Time to Overall Response of CR or PR - Percentage of Participants With an Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
measure: Time to Overall Response of CR or PR - Time to Event
timeFrame: Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
Other outcomes:
Locations:
city: Firenze
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Torino
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Del Vecchio M, Mortarini R, Canova S, Di Guardo L, Pimpinelli N, Sertoli MR, Bedognetti D, Queirolo P, Morosini P, Perrone T, Bajetta E, Anichini A. Bevacizumab plus fotemustine as first-line treatment in metastatic melanoma patients: clinical activity and modulation of angiogenesis and lymphangiogenesis factors. Clin Cancer Res. 2010 Dec 1;16(23):5862-72. doi: 10.1158/1078-0432.CCR-10-2363. Epub 2010 Oct 28.