Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or… (NCT00602082) | Clinical Trial Compass
CompletedPhase 2
Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors
United Kingdom84 participantsStarted 2005-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-tar…
What they're measuring
1
Objective response rate
Trial details
NCT IDNCT00602082
SponsorCambridge University Hospitals NHS Foundation Trust