Clinical trial NCT00227617
Conditions: Gastrointestinal Carcinoid Tumor Islet Cell Tumor Lung Cancer Neoplastic Syndrome Neuroendocrine Tumor
Keywords: recurrent gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor pulmonary carcinoid tumor gastrinoma insulinoma WDHA syndrome glucagonoma pancreatic polypeptide tumor somatostatinoma recurrent islet cell carcinoma metastatic gastrointestinal carcinoid tumor
Sponsor: University of California, San Francisco
Start date: 2005-06-08; Completion date: 2016-02-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
OBJECTIVES:

Primary

* Determine the safety of fluorouracil, leucovorin calcium, and oxaliplatin (FOLFOX) with bevacizumab in patients with advanced neuroendocrine tumors.
* Determine the best overall response rate in patients treated with this regimen.

Secondary

* Determine the overall survival of patients treated with this regimen.
* Determine the time to treatment failure and progression in patients treated with this regimen.
* Determine the biochemical marker response in patients treated with this regimen.

OUTLINE: This is an open-label, pilot study. Patients are stratified according to tumor type (carcinoid vs islet cell vs poorly differentiated neuroendocrine).

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 39-102 patients (13-34 per stratum) will be accrued for this study.

Arms: arm 1: 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
Interventions: intervention 1: bevacizumab intervention 2: 5-fluorouracil intervention 3: leucovorin intervention 4: oxaliplatin
Intervention descriptions: intervention 1: 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. intervention 2: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks. intervention 3: 200mg/m2 IV q2 wk on day 1 over a 2-hour period. intervention 4: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period

Protocol documents: