Temozolomide and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Sponsor
Swiss Cancer Institute
Study ID
NCT00568048
Phase
PHASE2
Status
Completed

Conditions

  • Melanoma (Skin)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    10 mg/kg i.v., on day 1 of every cycle (14 days) until PD or any other event qualifying for stopping treatment
  • temozolomide — DRUG
    150 mg/m2 p.o., on days 1-7 of every cycle (14 days) until PD or any other event qualifying for stopping treatment

Study Details

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temozolomide together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery.

Key Dates

First listed
Dec 5, 2007
Start date
Dec 31, 2007
Status verified
Apr 2013
Primary completion
Dec 31, 2010
Completion
Oct 31, 2011

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy Temozolomide & Bevacizumab
    Combination therapy * Temozolomide 150 mg/m2 p.o., days 1-7, repeated every 14 days * Bevacizumab 10 mg/kg i.v., day 1, repeated every 14 days

Primary Outcome Measure

Clinical benefit number of patients with complete response [CR], partial response [PR], or stable disease) according to RECIST criteria [ Time Frame: at 12 weeks ]

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