Clinical trial · Interventional
Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors
A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors
NCT00004922CI-TRIAL-00010791completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced neuroendocrine tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of Unknown Primary | Carcinoma of Unknown Primary | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Carcinoma of the Skin | Cutaneous Merkel Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven metastatic or unresectable high grade neuroendocrine tumor including: * Small cell carcinoma * Large cell neuroendocrine carcinoma * Other high grade neuroendocrine carcinomas without specification to cell size * No lung only involvement without any other primary site * No primary small cell lung cancer with or without metastases * Bidimensionally measurable disease with at least one lesion measuring at least 1 cm by 1 cm * High grade tumor indicated by at least one of the following: * Growth pattern suggestive of neuroendocrine differentiation * Mitotic rate greater than 15 mitoses per 10 hpf * Presence of abundant necrosis * Immunohistochemical evidence of neuroendocrine differentiation by positive staining for chromogranin, synaptophysin, or neuron specific enolase if no classic microscopic appearance of small cell carcinoma * No low grade neuroendocrine tumors (e.g., carcinoid tumors, pancreatic endocrine tumors) and atypical tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT no greater than 5 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No uncontrolled congestive heart failure requiring therapy Other: * No active or uncontrolled infection * HIV negative * No psychiatric or other disorder that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 2 prior chemotherapy regimens * No prior camptothecins Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.