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Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
This study has been completed.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002901
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Head and Neck Cancer
Lung Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: docetaxel
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: PHASE I STUDY OF TAXOTERE IN PATIENTS WITH ADVANCED MALIGNANCIES AND VARYING DEGREES OF LIVER DYSFUNCTION

Resource links provided by NLM:


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

Study Start Date: December 1996
Detailed Description:

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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002901

Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
Beckman Research Institute
Investigators
Study Chair: James H. Doroshow, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065241, CHNMC-PHI-08, CHNMC-IRB-96118, LAC-USC-PHI-08, NCI-T96-0028H
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002901     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
stage IV nasopharyngeal cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
unspecified adult solid tumor, protocol specific
recurrent metastatic squamous neck cancer with occult primary
ovarian stromal cancer
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III verrucous carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip

Study placed in the following topic categories:
Thoracic Neoplasms
Laryngeal Carcinoma
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Squamous Cell Carcinoma
Hypopharyngeal Cancer
Docetaxel
Genital Diseases, Female
Soft Tissue Sarcomas
Carcinoma, Adenoid Cystic
Respiratory Tract Diseases
Lung Neoplasms
Ovarian Cancer
Papilloma
Breast Diseases
Endocrine Gland Neoplasms
Nasopharyngeal Carcinoma
Ovarian Neoplasms
Skin Diseases
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Carcinoma, Basal Cell
Ovarian Epithelial Cancer
Granuloma
Recurrence
Carcinoma
Malignant Mesenchymal Tumor
Metastatic Squamous Neck Cancer With Occult Primary

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Ovarian Neoplasms
Skin Diseases
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases
Pharmacologic Actions
Adnexal Diseases
Docetaxel
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Head and Neck Neoplasms
Lung Diseases
Breast Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009