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Phase I and Pharmacokinetic Study of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Solid Tumors

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

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Trial Information

Phase I and Pharmacokinetic Study of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose of mitomycin when administered with
irinotecan in patients with advanced solid tumors. II. Determine whether the pharmacokinetic
profile of irinotecan is altered by prior administration of mitomycin in this patient
population. III. Determine the effect of irinotecan and mitomycin on the expression of
DT-Diaphorase and the Topo I gene. IV. Determine the preliminary antitumor activity of this
regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive mitomycin IV over 20 to 30
minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2
weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of
disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive
escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is
reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences
dose limiting toxicity. Patients are followed for 1 month.

PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumors for which no
standard therapy exists or that is persistent or recurrent following prior therapy
Measurable or evaluable disease No hematologic malignancies (e.g., leukemia or lymphoma)
No known brain or leptomeningeal disease (unless lesions have been irradiated, are
currently untreated with corticosteroids, and have no clinical symptoms)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Karnofsky 70-100%
Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic:
Bilirubin less than 1.5 times upper limit of normal (ULN) AST and ALT less than 3 times
ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
Calcium no greater than 12 mg/dL Cardiovascular: No myocardial infarction within 6 months
No congestive heart failure requiring therapy No unstable angina Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception No
active infection No other concurrent severe disease No psychiatric disorders No history of
seizure disorders No uncontrolled diabetes (blood sugar no greater than 200 mg/dL)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No
prior mitomycin, irinotecan, or nitrosoureas No more than 6 courses of chemotherapy
containing an alkylating agent No more than 4 courses of carboplatin Endocrine therapy: At
least 4 weeks since prior endocrine therapy and recovered Radiotherapy: At least 4 weeks
since prior radiotherapy and recovered No prior radiotherapy to more than 20% of bone
marrow No prior whole pelvis radiotherapy Surgery: Not specified Other: No concurrent
phenytoin, phenobarbital, valproic acid, or other antiepileptic prophylaxis No concurrent

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ronald L. Drengler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

South Texas Oncology and Hematology - Wurzbach Road


United States: Food and Drug Administration

Study ID:




Start Date:

August 1998

Completion Date:

May 2001

Related Keywords:

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



San Antonio Cancer Institute San Antonio, Texas  78229-3264