Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed unresectable, advanced, and/or metastatic disease meeting one of the following types:
• •* Gastroentero-neuroendocrine tumor of the foregut
• •* Pancreatic neuroendocrine tumor
• •* Neuroendocrine tumor of unknown primary
• •Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (the longest diameter) ≥ 20 mm by conventional CT scanning or ≥ 10 mm by spiral CT scan or MRI
• •No bronchial neuroendocrine tumors (NETs) or other NETs where the primary site is situated in organs above the diaphragm (e.g., laryngeal and pharyngeal NETs)
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy ≥ 12 weeks
• •Hemoglobin ≥ 10 g/dL
• •Platelet count ≥ 100,000/mm³
• •WBC ≥ 3,000/mm³
• •ANC ≥ 1,500/mm³
• •Bilirubin ≤ 2 times upper limit of normal (ULN)
• •Alkaline phosphatase ≤ 5 times ULN
• •AST and ALT ≤ 5 times ULN
• •GFR ≥ 60 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• •No other serious or uncontrolled illness that would preclude study participation
• •No medical or psychiatric condition that would influence the ability to provide consent
• •PRIOR CONCURRENT THERAPY:
• •At least 3 weeks since prior interferon therapy
• •No prior systemic chemotherapy or chemotherapy administered as part of a chemo-embolization regimen, or for this condition
• •No receptor-targeted radiolabeled therapy within the past 6 months
• •No investigational agent within the past 4 weeks
• •Prior and concurrent somatostatin analogues allowed provided symptoms are no longer controlled by this treatment or there is documented measurable disease progression on serial CT scans performed up to 6 months apart
• •No palliative radiotherapy involving lesions used to measure disease
• •* Palliative radiotherapy to regions not involved in measurement of disease allowed
• •No other concurrent chemotherapy for this condition