Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Irinotecan

Criteria

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