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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Notify MeKey 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
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
Primary outcomes
-
Overall survival
Time frame: Up to 5 years
-
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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