Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003742
Recruitment Status : Completed
First Posted : March 15, 2004
Last Update Posted : June 21, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: cisplatin Drug: irinotecan hydrochloride Drug: paclitaxel Phase 1

Detailed Description:

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 death.

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

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Trial of Paclitaxel, Cisplatin, and Irinotecan in Patients With Advanced Solid Tumor Malignancies
Study Start Date : October 1998
Actual Primary Completion Date : August 2001
Actual Study Completion Date : August 2001

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 meningitis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003742

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David H. Ilson, MD, PhD Memorial Sloan Kettering Cancer Center Identifier: NCT00003742     History of Changes
Other Study ID Numbers: 98-100
CDR0000066860 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 15, 2004    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors