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Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when combined with
docetaxel in patients with advanced solid malignancies. II. Determine the dose limiting
toxicity of this regimen in these patients. III. Assess any antitumor activity of this
regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of irinotecan. Patients receive
docetaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes on days 1, 8,
15, and 22. Treatment continues every 6 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 of 6 patients experience dose limiting toxicity. Patients are followed every
3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven solid malignancy for which no effective
therapy is currently available CNS metastases allowed if CNS disease is stable for at
least 4 weeks following completion of surgery and/or radiotherapy

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: At least 3 months Life
expectancy: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin less than 1.2 mg/dL SGOT and/or SGPT no
greater than 1.5 times upper limit of normal (ULN) (no greater than 2.5 times ULN allowed
if alkaline phosphatase no greater than ULN) Alkaline phosphatase no greater than 2.5
times ULN (no greater than 4 times ULN allowed if SGOT and/or SGPT no greater than ULN)
Renal: Creatinine clearance at least 55 mL/min Other: HIV negative No active infection Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No concurrent medical condition that would preclude compliance with study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy regimens containing topotecan, irinotecan, or docetaxel At least 4 weeks
since other prior chemotherapy (6 weeks since prior nitrosoureas, melphalan, or mitomycin)
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4
weeks since prior wide field radiotherapy No prior radiotherapy to greater than 20% of
bone marrow Surgery: See Disease Characteristics Recovered from any prior surgery Other:
No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John R. Murren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

May 2006

Related Keywords:

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



Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Bennett Cancer Center Stamford, Connecticut  06902