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A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Malignant Melanoma

Interventions: bevacizumab [Avastin], fotemustine

Countries: Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (4)

Florence, Italy
Genova, Italy
Milan, Italy
Torino, Italy