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Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00004923
Recruitment Status : Completed
First Posted : April 28, 2004
Last Update Posted : August 25, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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/II trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: docetaxel Drug: irinotecan hydrochloride Phase 1 Phase 2

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Primary Purpose: Treatment
Official Title: Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer
Study Start Date : April 1999
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00004923


Locations
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
Bennett Cancer Center
Stamford, Connecticut, United States, 06902
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Investigators
Study Chair: John R. Murren, MD Yale University
More Information

ClinicalTrials.gov Identifier: NCT00004923     History of Changes
Other Study ID Numbers: CDR0000067606
YALE-HIC-10023
NCI-G00-1700
First Posted: April 28, 2004    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by Yale University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Docetaxel
Irinotecan
Camptothecin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors