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Home > "D" Clinical Trials Conditions > Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors  Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Yale Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnMurren, Study Chair, Yale Cancer Center
Bennett Cancer Center
Stamford, Connecticut, 06902
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Additional Information:
Study ID Numbers: CDR0000067606; YALE-HIC-10023,NCI-G00-1700
Study Start Date: April 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004923
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
2. Evaluating Patient Participation in Phase I Clinical Trials
3. Vaccine Therapy With or Without Sargramostim in Treating Patients With Cancer
4. 3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
5. Cisplatin, Gemcitabine, Interferon alfa, and Hyperthermia in Treating Patients With Advanced Cancer
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Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
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