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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving capecitabine together with streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.

PURPOSE: This randomized phase II trial is studying giving capecitabine together with streptozocin to see how well it works compared with or without cisplatin in treating patients with unresectable or metastatic neuroendocrine tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Treatments: Capecitabine; Cisplatin; Streptozocin

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