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A Phase I Study of Oxaliplatin, CPT-11, 5-FU and Leucovorin in Patients With Solid Tumors

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

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Trial Information

A Phase I Study of Oxaliplatin, CPT-11, 5-FU and Leucovorin in Patients With Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan, fluorouracil, and
leucovorin calcium (Saltz regimen vs Mayo regimen) plus oxaliplatin (arm I vs arm II) in
patients with metastatic or unresectable solid tumors. II. Determine the effect of
irinotecan on the disposition of oxaliplatin in these patients. III. Assess the development
of peripheral neuropathy in these patients on the Mayo regimen. IV. Determine the activity
of these regimens in patients with metastatic solid tumors.

OUTLINE: This is a dose escalation study. Patients are entered to one of two treatment arms:
Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes, leucovorin calcium
IV, and fluorouracil IV on days 1, 8, 15, and 22, followed by oxaliplatin IV over 2 hours on
days 1 and 15. Courses repeat every 6 weeks. Arm II (Mayo regimen): Patients receive
irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1, followed by
leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every
3 weeks. Cohorts of 3-6 patients receive escalating doses of fluorouracil (one of two
treatment doses for arm II), and one of two treatment doses of irinotecan and oxaliplatin
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are
followed for 3 months.

PROJECTED ACCRUAL: Up to 60 patients will be accrued for this study within 8-14 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable solid tumor for
which no standard or curative therapy exists No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal
(ULN) AST no greater than 5 times ULN Renal: Creatinine normal OR Creatinine clearance at
least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina
pectoris No cardiac arrhythmias No New York Heart Association class III or IV heart
disease Neurologic: No peripheral neuropathy grade 2 or greater No uncontrolled seizure
disorders Other: Not pregnant or nursing Fertile patients must use effective contraception
No uncontrolled concurrent illness No active infection No history of allergy to platinum
compounds, irinotecan, antiemetics, or antidiarrheals

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy At
least 4 weeks since prior biologic therapy No concurrent immunotherapy Chemotherapy: At
least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and
recovered No greater than 3 prior chemotherapy regimens for metastatic disease No other
concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic
radiotherapy At least 4 weeks since other prior radiotherapy No prior radiotherapy to
greater than 25% of bone marrow No concurrent radiotherapy Surgery: Not specified Other:
No concurrent antiretroviral therapy for HIV positive patients

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard M. Goldberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

June 2003

Related Keywords:

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



Mayo Clinic Rochester, Minnesota  55905