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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function  Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
For Condition: Breast Cancer,Lung Cancer,Oropharyngeal Cancer,ovarian sarcoma,Head and Neck Cancer,ovarian epithelial cancer,lip and oral cavity cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of docetaxel in treating patients with advanced solid tumors that have not responded to standard therapy or for which there is no effective therapy.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel in patients with advanced solid tumors and varying degrees of liver dysfunction. II. Determine the effects of liver dysfunction in these patients on the plasma pharmacokinetics and pharmacodynamics of this therapy. III. Determine the utility of indocyanine green clearance and lidocaine metabolism as indicators of hepatic elimination of docetaxel in these patients. PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild vs moderate vs severe). Patients receive docetaxel IV over 1 hour. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Within each abnormal liver function stratum, cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Within each abnormal liver function stratum, more than 6 patients are treated at the MTD, if possible. Patients in the normal liver function stratum are included as control patients and are followed for toxicity, but do not undergo dose escalation. Patients are followed for survival. PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven solid tumor that is refractory to standard therapy or for which no standard therapy exists; Eligible tumors, include, but are not limited to, the following: Breast; Ovarian; Head and neck; Non-small cell lung cancer; Abnormal liver function - Control patients with normal liver function are enrolled - Brain metastases allowed if controlled by radiotherapy or surgery and neurologic status currently stable - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No prior bone marrow transplantation - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy and recovered; No prior radiotherapy to more than 25% of bone marrow - Surgery: See Disease Characteristics; Recovered from major surgery --Patient Characteristics-- - Age: 18 and over - Sex: Not specified - Menopausal status: Not specified - Performance status: Karnofsky 50-100% - Life expectancy: At least 1 month - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL OR Hematocrit at least 35% - Hepatic: See Disease Characteristics; No active acute hepatitis - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No concurrent cardiovascular disease that is poorly controlled with currently available treatment or of such severity as to preclude study - Pulmonary: No concurrent pulmonary disease that is poorly controlled with currently available treatment or of such severity as to preclude study - Other: No other concurrent illness (e.g., CNS disease) that is poorly controlled with currently available treatment or of such severity as to preclude study; No severe infection requiring treatment; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesDoroshow, Study Chair, Beckman Research Institute
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000065241; CHNMC-PHI-08,NCI-T96-0028H,LAC-USC-PHI-08
Study Start Date: December 1996
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002901
Other Lip And Oral Cavity Cancer Studies:
1. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
2. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
3. Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
4. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
5. Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
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Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
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