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Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors

NCT00227617 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-05-22

Study results available
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Summary

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.

Conditions

  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • Lung Cancer
  • Neoplastic Syndrome
  • Neuroendocrine Tumor

Interventions

BIOLOGICAL

bevacizumab

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.

DRUG

5-fluorouracil

2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.

DRUG

leucovorin

200mg/m2 IV q2 wk on day 1 over a 2-hour period.

DRUG

oxaliplatin

200mg/m2 IV q 2 wk on day 1 over a 2-hour period

Sponsors & Collaborators

Principal Investigators

  • Emily K. Bergsland, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-08
Primary Completion
2012-01-31
Completion
2016-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00227617 on ClinicalTrials.gov