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Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Yale University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004923
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: docetaxel
Drug: irinotecan hydrochloride
Phase I
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Docetaxel    Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004923

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

Sponsors and Collaborators

Investigators
Study Chair:     John R. Murren, MD     Yale University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067606, YALE-HIC-10023, NCI-G00-1700
First Received:   March 7, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004923
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Docetaxel
Irinotecan
Camptothecin

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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