Paclitaxel in Treating Older Patients With Solid Tumors

Clinical Pharmacology of Paclitaxel in Relation to Patient Age

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.

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).

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