Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT00227617
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
  • 5-fluorouracil — DRUG
    2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
  • leucovorin — DRUG
    200mg/m2 IV q2 wk on day 1 over a 2-hour period.
  • oxaliplatin — DRUG
    200mg/m2 IV q 2 wk on day 1 over a 2-hour period

Study Details

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, 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 neuroendocrine tumors by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with advanced neuroendocrine tumors.

Key Dates

First listed
Sep 28, 2005
Start date
Jun 8, 2005
Status verified
Dec 2019
Primary completion
Jan 31, 2012
Completion
Feb 29, 2016

Study Design

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

Arms

  • Experimental: FOLFOX with Bevacizumab
    Starting on Day 1, administered every two weeks: 5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes

Primary Outcome Measure

Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment [ Time Frame: From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Univeristy of California, San FranciscoSan FranciscoCalifornia94115-
Kaiser Permanente Medical Center - VallejoVallejoCalifornia94589-

Find similar trials in San Francisco, CA

By condition
Lung cancerNeuroendocrine tumors
By specialty
OncologyLung oncologyLung disease
By research site
Univeristy of California, San Francisco· San Francisco, CAKaiser Permanente Medical Center - Vallejo· Vallejo, CA

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