Paclitaxel in Treating Older Patients With Solid Tumors

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients who have solid tumors.

Detailed Description
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OBJECTIVES: Determine whether there is a relationship between pharmacokinetic measurements of paclitaxel and aging. Determine whether there is a relationship between the toxic effects of paclitaxel and aging. OUTLINE: Patients are stratified according to age (cohort 1: patients 55 to 64 vs cohort 2: patients 65 to 75 vs cohort 3: patients 75 and over).

Official Title
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Clinical Pharmacology of Paclitaxel in Relation to Patient Age

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven nonhematologic malignancy PATIENT CHARACTERISTICS: Age: 55 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.0 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled or severe cardiovascular disease Other: No serious intercurrent medical illnesses that in the judgement of the investigator compromise patient care No psychiatric conditions that would preclude study No requirement for antibiotics for active acute infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No more than one prior chemotherapy regimen allowed No prior paclitaxel allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiation therapy Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel<br>Patients receive a single dose of IV paclitaxel over 3 hours. Additional cycles of paclitaxel will be given at the discretion of the physician. Patients are followed for second malignancies, disease progression, and survival. | Drug: paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to 5 years | 
| Disease-free progression |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific