Clinical trial · Interventional
Irinotecan in Treating Aging Patients With Solid Tumors
Clinical Pharmacology In The Elderly: Prospective Evaluation Of The Pharmacokinetics, Pharmacogenetics And Pharmacodynamics Of CPT-11 And Aging
NCT00026195CI-TRIAL-00022908completedPhase 1ClinicalTrials.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. Aging may affect the way these drugs work. PURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of irinotecan in treating 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 |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinotecan
- description
- Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.
- interventionNames
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-hematologic malignancy * Brain metastases or primary brain tumors are eligible provided patient is not receiving steroids or antiepileptic medications PATIENT CHARACTERISTICS: Age: * 18 to 55 or 70 and over Performance status: * CTC 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT no greater than ULN Renal: * Creatinine no greater than ULN Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea) * No more than 1 prior chemotherapy regimen for metastatic disease (no limit if administered in the adjuvant setting) * No prior camptothecin Endocrine therapy: * See Disease Characteristics Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy, including for palliation Surgery: * At least 4 weeks since prior major surgery
References
Publications (0)
Data not yet available
No reference posted for this study.