Completed

Clinical Pharmacology of Paclitaxel in Relation to Patient Age

What is being tested

paclitaxel

Drug

Who is being recruted

Over 55 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: September 1997

See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology

Last updated: July 14, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1997

Actual date on which the first participant was enrolled.

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).

NCT00003092

Principal SponsorAlliance for Clinical Trials in Oncology

Last updated: July 14, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Rebecca and John Moores UCSD Cancer Center

La Jolla, United StatesOpen Rebecca and John Moores UCSD Cancer Center in Google Maps

UCSF Cancer Center and Cancer Research Institute

San Francisco, United States

CCOP - Christiana Care Health Services

Wilmington, United States

Walter Reed Army Medical Center

Washington D.C., United States

Completed32 Study Centers