Clinical trial · Interventional
Paclitaxel in Treating Older Patients With Solid Tumors
Clinical Pharmacology of Paclitaxel in Relation to Patient Age
NCT00003092CI-TRIAL-00023081completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel
- description
- 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.
- interventionNames
- Drug: paclitaxel
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- Up to 5 years
- measure
- Disease-free progression
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTLichtman SM, Hollis D, Miller AA, Rosner GL, Rhoades CA, Lester EP, Millard F, Byrd J, Cullinan SA, Rosen DM, Parise RA, Ratain MJ, Egorin MJ; Cancer and Leukemia Group B (CALGB 9762). Prospective evaluation of the relationship of patient age and paclitaxel clinical pharmacology: Cancer and Leukemia Group B (CALGB 9762). J Clin Oncol. 2006 Apr 20;24(12):1846-51. doi: 10.1200/JCO.2005.03.9289. Epub 2006 Mar 27. PMID 16567769
- RESULTLichtman SM, Egorin M, Rosner G, et al.: Clinical pharmacology of paclitaxel in relation to patient age: CALGB 9762. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A732, 1999.