A Phase II Study of Capecitabine, Oxaliplatin and Bevacizumab for Metastatic or Unresectable Neuroendocrine Tumors
Given the lack of other viable treatment options for metastatic neuroendocrine tumors, contrasted with our positive anecdotal experience, and the relative tolerability of the treatment regimen for colorectal cancer patients, we propose a single-institution phase II trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Capecitabine
- drug : Bevacizumab
- drug : Oxaliplatin
Phase: Phase 2
Ages Eligible For Study:
Subjects must be treated at Stanford University Medical Center for the entire length of study participation. - Patients must have histologically or cytologically confirmed neuroendocrine tumor, including both well-differentiated tumors (carcinoid) or moderately to poorly differentiated tumors. Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, or presence of metastasis. - Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases. - Prior chemotherapy will be permitted, although the patient may not have had prior oxaliplatin. - Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (see Section 4.2) within 4 weeks prior to entry of study - Patients must have ECOG performance status of 0-2 - Patients must be >= 18 years of age - Laboratory values <= 2 weeks prior to randomization: - Absolute Neutrophil Count (ANC) >=1500/mm3 - Platelets (PLT) >= 100,000/mm3 - Hemoglobin (Hgb) >= 9 g/dL - Serum creatinine <= 1.5 x ULN - Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if liver metastases present) - Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and alkaline phosphatase <= 3.0 x ULN (<= 5.0 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests. - Life expectancy >= 12 weeks - Ability to give written informed consent according to local guidelines