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

OBJECTIVES: I. Determine the maximum tolerated dose of paclitaxel when combined with
cisplatin and irinotecan in patients with locally advanced or metastatic solid tumors. II.
Determine the dose limiting toxicity of paclitaxel when combined with cisplatin and
irinotecan in this patient population. III. Establish the recommended phase II dose for this
regimen in this patient population. IV. Assess the antitumor activity of this regimen in
selected solid tumor malignancies.

OUTLINE: This is a dose escalation study of paclitaxel. All patients receive paclitaxel IV
over 1 hour, then cisplatin IV over 30 minutes, followed by irinotecan IV over 30 minutes
weekly for 4 weeks on days 1, 8, 15, and 22. Treatment is repeated every six weeks for at
least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of
3-6 patients receive escalating doses of paclitaxel. If 2 or more patients experience dose
limiting toxicity (DLT) at a particular dose level, escalation ceases and the maximum
tolerated dose (MTD) is defined as the previous dose level. Patients are followed until

PROJECTED ACCRUAL: Approximately 12-27 patients will be accrued for this study within 6-9

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven locally advanced (unresectable or
recurrent) or metastatic solid tumor No bone metastases, abnormal radionuclide bone scan
or pleural effusions as the sole indicators of disease No CNS metastases or carcinomatous

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) (no greater than 5 times ULN if
liver metastases present) No Gilbert's Disease Renal: Creatinine no greater than 1.5 mg/dL
Serum calcium less than 12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No
unstable angina No active angina No New York Heart Association class III or IV heart
disease No uncontrolled asymptomatic congestive cardiac failure At least 6 months since
any myocardial infarction Pulmonary: No interstitial pulmonary fibrosis Other: No history
of seizure disorder and receiving phenytoin, phenobarbital, or other antiepileptic
medication No active or uncontrolled infection No uncontrolled diabetes mellitus Not
pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior
chemotherapy regimen allowed Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since prior radiotherapy and recovered No prior mantle, hemibody, pelvic, or lumbar
spine irradiation Surgery: Not specified

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 1998

Completion Date:

August 2001

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