Trial Information

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

Status: Recruiting

Protocol Number: ML20383

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open label study to evaluate the effect of Avastin in association with chemotherapy on progression-free survival in patients with progressive advanced/metastatic well-differentiated digestive endocrine tumors of the gastrointestinal tract

Brief Summary: 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. Target sample size is 84.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Neoplasms

Intervention Type: Drug

Intervention Name: bevacizumab [Avastin]

Primary Outcome: 1. Median progression-free survival Time frame: Event driven

Key Secondary Outcomes: 1. Overall disease control rate, overall survival. Time frame: Event driven 2. AEs, SAEs. Time frame: Throughout study

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors;
  • no previous anti-cancer therapy, other than surgery;
  • progressive metastatic disease;
  • >=1 measurable lesion.

Exclusion Criteria:

  • abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ECG;
  • patients with known bleeding disorders;
  • unstable systemic disease;
  • chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;
  • previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 2007

Trial Registration Date: 03/19/2007

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Rouen, France, 76031
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 7, 2008 at 2:40:04 PM


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