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OpenTrials
Completed

NCT Number: NCT00003092

Paclitaxel in Treating Older Patients With Solid Tumors

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

Primary outcomes

  1. Overall survival

    Time frame: Up to 5 years

  2. Disease-free progression

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Clinical Pharmacology of Paclitaxel in Relation to Patient Age

Important dates

Study start
1997
Primary completion
2006
Study completion
2006
First posted
Jan 27, 2003
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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