Paclitaxel in Treating Older Patients With Solid Tumors

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: paclitaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003092

CDR0000065800 (Registry Identifier)

CALGB-9762

U10CA031946 (U.S. NIH Grant/Contract)

CLB-9762

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 120 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Paclitaxel

Experimental group

Description:

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.

Treatment:

Drug: paclitaxel