Paclitaxel in Treating Older Patients With Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Clinical Pharmacology of Paclitaxel in Relation to Patient Age |
| Study Start Date: | September 1997 |
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 (closed to accrual 6/23/2000) vs cohort 2: patients 65 to 74 (closed to accrual 9/29/2000) vs cohort 3: patients 75 and over).
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.
PROJECTED ACCRUAL: A total of 120 patients (40 patients per cohort) will be accrued for this study within 2 or 3 years.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 32 Study Locations| Study Chair: | Stuart M. Lichtman, MD | Don Monti Comprehensive Cancer Center at North Shore University Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003092 History of Changes |
| Other Study ID Numbers: | CDR0000065800, CLB-9762 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013