Paclitaxel in Treating Older Patients With Solid Tumors
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 55 - Any |
Updated: | 4/21/2016 |
Start Date: | September 1997 |
End Date: | June 2006 |
Clinical Pharmacology of Paclitaxel in Relation to Patient Age
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.
so they stop growing or die.
PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients
who have solid tumors.
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).
- 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).
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
We found this trial at
32
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6900 Georgia Ave NW
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Medical Center Boulevard
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Worcester, Massachusetts 01655
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