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PHASE I STUDY OF TAXOTERE IN PATIENTS WITH ADVANCED MALIGNANCIES AND VARYING DEGREES OF LIVER DYSFUNCTION


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

PHASE I STUDY OF TAXOTERE IN PATIENTS WITH ADVANCED MALIGNANCIES AND VARYING DEGREES OF LIVER DYSFUNCTION


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James H. Doroshow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000065241

NCT ID:

NCT00002901

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Breast Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • recurrent verrucous carcinoma of the oral cavity
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • recurrent adenoid cystic carcinoma of the oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III inverted papilloma of the paranasal sinus and nasal cavity
  • stage III midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • borderline ovarian surface epithelial-stromal tumor
  • ovarian sarcoma
  • Breast Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Ovarian Neoplasms

Name

Location

Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817