Paclitaxel in Treating Older Patients With Solid Tumors

Clinical Pharmacology of Paclitaxel in Relation to Patient Age

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003092

Enrollment

120

Registered

2003-01-27

Start date

1997-09-30

Completion date

2006-06-30

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief summary

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

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).

Interventions

DRUGpaclitaxel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Overall survival	Up to 5 years
Disease-free progression	Up to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026