A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.

Sponsor
Hoffmann-La Roche
Study ID
NCT00448136
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    7.5mg/kg iv on day 1 every 3 weeks
  • 5 FU — DRUG
    400mg/m2/day iv on days 1-5 every 6 weeks
  • Streptozotocin — DRUG
    500mg/m2/day iv on days 1-5 every 6 weeks
  • Xeloda — DRUG
    1000mg/m2 po bid on days 1-14 every 3 weeks

Study Details

This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.

Key Dates

First listed
Mar 16, 2007
Start date
Jul 31, 2007
Status verified
Jan 2015
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
83 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years ]

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