ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function

This study has been completed.

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

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Head and Neck Cancer    Lung Cancer    Ovarian Cancer   

ChemIDplus related topics:   Docetaxel    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

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

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
National Cancer Institute (NCI)

Investigators
Study Chair:     James H. Doroshow, MD     Beckman Research Institute    
  More Information


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

Study ID Numbers:   CDR0000065241, CHNMC-PHI-08, CHNMC-IRB-96118, LAC-USC-PHI-08, NCI-T96-0028H
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002901
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
Gonadal Disorders
Squamous cell carcinoma
Malignant mesenchymal tumor
Sodium Salicylate
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Adenoid cystic carcinoma
Soft tissue sarcomas
Docetaxel
Genital Diseases, Female
Carcinoma, Adenoid Cystic
Respiratory Tract Diseases
Lung Neoplasms
Metastatic squamous neck cancer with occult primary
Carcinoma, squamous cell
Laryngeal carcinoma
Papilloma
Breast Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Non-small cell lung cancer
Ovarian Neoplasms
Skin Diseases
Salicylsalicylic acid
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Carcinoma, Basal Cell

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on October 15, 2008




Links to all studies - primarily for crawlers