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A Phase I Study to Evaluate Orally Administered Irinotecan HCL (CPT-11) Given as a Powder-Filled Capsule Formulation Daily for 14 Days Every Three Weeks in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study to Evaluate Orally Administered Irinotecan HCL (CPT-11) Given as a Powder-Filled Capsule Formulation Daily for 14 Days Every Three Weeks in Patients With Advanced Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and safety
profile of oral irinotecan in patients with advanced solid tumors. II. Characterize the
single and multiple dose pharmacokinetics of oral irinotecan and its metabolites, SN-38 and
SN-38 glucuronide, in these patients. III. Document any antitumor activity in these patients
treated with this regimen.

OUTLINE: This is a dose escalation study. Patients receive oral irinotecan once daily for 14
days. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
or more of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6

PROJECTED ACCRUAL: Approximately 3-40 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced solid tumor for which no curative
therapy exists No leukemias or lymphomas Brain or leptomeningeal disease allowed only if
prior irradiation of these lesions, no concurrent corticosteroids, and no clinical

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count
at least 150,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5
mg/dL regardless of liver tumor presence SGOT no greater than 3 times upper limit of
normal (ULN) (5 times ULN if due to liver tumor) Renal: Creatinine no greater than 2.0
mg/dL Cardiovascular: No uncontrolled high blood pressure No unstable angina No
symptomatic congestive heart failure No myocardial infarction within past 6 months No
serious uncontrolled cardiac arrhythmia Gastrointestinal: No active inflammatory bowel
disease No significant bowel obstruction No chronic malabsorption Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No
active infection HIV negative No AIDS related illness No significant alcoholism or
substance abuse No severe medical or psychiatric illness that would preclude participation
in study

PRIOR CONCURRENT THERAPY: At least 4 weeks since prior therapy for cancer and recovered
Biologic therapy: No concurrent immunotherapy No concurrent filgrastim (G-CSF),
sargramostim (GM-CSF), or epoetin alfa Chemotherapy: No prior nitrosoureas, mitomycin, or
irinotecan No prior high dose chemotherapy in support of peripheral blood stem cell
transplantation No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal
therapy Radiotherapy: No prior irradiation of pelvis No concurrent radiotherapy Surgery:
No prior gastrectomy or total colectomy Other: At least 1 week since prior anticonvulsants
No other concurrent investigational drugs No combination anticholinergic medications
containing barbiturates (e.g., Donnatol)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021