Status and phase
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About
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.
Full description
OBJECTIVES:
Primary
Secondary
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed neuroendocrine tumor (NET)
Carcinoid at any site, with or without carcinoid syndrome
Pancreatic islet cell tumor
Poorly differentiated NET of any primary site (this arm closed to accrual May 2009)
The following tumors are not allowed:
Advanced disease
Radiologically or clinically confirmed progressive disease
Measurable disease
At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional radiographic techniques OR ≥ 10 mm by spiral CT scan
Bone lesions, ascites, peritoneal carcinomatosis, pleural or pericardial effusion, and irradiated lesions are not considered measurable disease
Primary tumors of the pancreas should not invade adjacent organs (e.g., stomach or duodenum)
No history or evidence of brain or leptomeningeal disease (baseline CNS imaging required if clinical suspicion of CNS metastases)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
History of thromboembolic condition allowed provided patient is on therapeutic anticoagulation at a stable dose for ≥ 4 weeks
No uncontrolled hypertension, myocardial infarction, clinically significant peripheral arterial ischemia, visceral arterial ischemia or angina within the past 6 months
No serious cardiac arrhythmia requiring medication
No cerebrovascular event (e.g., stroke or transient ischemic attack) within the past 12 months
No history of peripheral vascular disease ≥ grade 2
No history New York Heart Association class II-IV congestive heart failure
Blood pressure ≤ 160/90 mm Hg
Gastrointestinal
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
No predisposing uncontrolled small bowel or colonic disorder
No gastric or esophageal varices
No gastroduodenal ulcers determined to be active by endoscopy
Pulmonary
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
No significant traumatic injury within the past 28 days
No currently active second malignancy other than, non-melanoma skin cancer or carcinoma in situ
No known hypersensitivity reaction attributed to study drugs or to compounds of similar chemical or biological composition
No symptomatic peripheral neuropathy > grade 1
No other severe disease or comorbidity that would preclude study participation
No medically uncontrolled seizures
No active infection
No serious non-healing wound, ulcer, or bone fracture
No psychiatric illness or social situation that would preclude study compliance
No other severe, concurrent disease, infection, or co-morbidity that in the judgement of the investigator would constitute a hazard for study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy to only site of measurable disease
Surgery
Other
Primary purpose
Allocation
Interventional model
Masking
36 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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