Low accrual
A Pilot Study of FOLFOX in Combination With Bevacizumab in Patients With Advanced Neuroendocrine Tumors
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI Clinical Trials Reporting Program
interventional
36
1 country
2
Study Start
June 8, 2005
Actual (reported)Primary Completion
January 2012
Actual (reported)Study Completion
February 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 8, 2005
Actual (reported)September 26, 2005
Actual (reported)September 28, 2005
Actual (reported)January 2012
Actual (reported)February 2016
Actual (reported)December 26, 2019
Actual (reported)Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment
Rates of discontinuation were calculated as counts and percentages of patients whom discontinued treatment due to adverse events possibly related to the investigational treatments not including neuropathy.
From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years
Best Objective Response
Best Objective Response by RECIST with Exact 95% Binomial CIs across all tumor types. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria Target lesions response + Non-Target lesions response + Evaluation of non-target lesions (Yes / No) = Overall response
From Baseline until disease progression, up to 8 years
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
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.
Univeristy of California, San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589, United States
Early termination leading to small numbers of subjects analyzed; Technical problems with database migration lead to missing treatment assignment values.
Emily K. Bergsland, MD
University of California, San Francisco
36 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2005
First Posted
September 28, 2005
Study Start
June 8, 2005
Actual (reported)Time to Progression
From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years
Overall Median Survival
until death, up to 8 years
Overall Time to Treatment Failure
From initial complete or partial response to disease progression, up to 8 years
Biochemical Marker Response
From Baseline until end of treatment, up to 8 years
2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
200mg/m2 IV q2 wk on day 1 over a 2-hour period.
200mg/m2 IV q 2 wk on day 1 over a 2-hour period
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2012
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
May 22, 2023
Results First Posted
December 26, 2019
Record last verified: 2019-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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