Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Carcinoma of Unknown Primary; Neuroendocrine Carcinoma of the Skin; Neuroendocrine Carcinoma

Treatments: Drug: irinotecan hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004922

NCI-G00-1683

CDR0000067605 (Registry Identifier)

99-041

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors.
• Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 10-31 patients will be accrued for this study.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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