Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1996-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Docetaxel in Treating Patients With Solid Tumors

NCT00003565

Bladder Cancer Breast Cancer Head and Neck Cancer +2 more

COMPLETED PHASE2

Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer

NCT00059943

Breast Cancer Lung Cancer Prostate Cancer

COMPLETED PHASE2

Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors

NCT00253344

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

NCT00002587

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Liposomal Doxorubicin in Treating Patients With Liver or Bile Duct Cancer

NCT00003296

Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Head and Neck Cancer Lung Cancer Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

docetaxel

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No