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Phase I Trial of Irinotecan, Cisplatin, and Fluorouracil in Patients With Advanced Solid Tumor Malignancies

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

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Trial Information

Phase I Trial of Irinotecan, Cisplatin, and Fluorouracil in Patients With Advanced Solid Tumor Malignancies

OBJECTIVES: I. Determine the maximum tolerated dose of weekly irinotecan in combination with
weekly fluorouracil and cisplatin in patients with locally advanced or metastatic solid
tumors. II. Determine the dose limiting toxicity for this combination regimen in this
patient population. III. Establish a recommended phase II dose for this combination regimen
in these patients. IV. Evaluate the safety and tolerability of this regimen in these
patients. V. Observe any responses to this combination chemotherapy in these patients. VI.
Measure in pretreatment biopsies levels of expression of thymidylate synthase, topoisomerase
I, ERCC-1, thymidine phosphorylase, and dihydropyrimidine dehydrogenase as correlates to
response or resistance to this combination chemotherapy in these patients.

OUTLINE: This is a dose escalation study of irinotecan and fluorouracil. Patients receive
cisplatin IV over 30 minutes followed by fluorouracil IV over several minutes followed by
irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Treatment continues every 6 weeks in
the absence of unacceptable toxicity or disease progression for a minimum of 3 courses.
Cohorts of 3-6 patients receive escalating doses of irinotecan and fluorouracil until the
maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding
that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients are
followed at 30 days and then until death.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1-2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed solid tumor malignancy not amenable to
curative surgery or chemoradiation No CNS metastases, carcinomatous meningitis, or
interstitial pulmonary fibrosis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL
AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases)
No known Gilbert's disease Renal: Creatinine no greater than 1.5 mg/dL Calcium less than
12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No unstable angina No New York
Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No active or uncontrolled
infection No history of seizure disorder No uncontrolled diabetes mellitus, defined as
random blood sugar 250 mg/dL or greater

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and
recovered No prior mantle irradiation, hemibody irradiation, or radiation to the pelvis or
lumbar spine Surgery: See Disease Characteristics Other: No concurrent phenytoin,
phenobarbital, or other antiepileptic medication No concurrent prochlorperazine on day of
irinotecan administration No concurrent prophylactic loperamide

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David H. Ilson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 1999

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