Clinical trial · Interventional
Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer
NCT00003225CI-TRIAL-00046382completedPhase 1 / Phase 2ClinicalTrials.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 I/II trial to study the effectiveness of amifostine plus irinotecan in treating patients with metastatic colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ethyol plus Irinotecan
- description
- Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. 10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV.
- interventionNames
- Drug: amifostine trihydrate
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule.
- timeFrame
- 12 weeks
Secondary outcomes (5)
- measure
- To assess the total dose of Irinotecan received per 6 week cycle
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * ECOG 0-2 * Life expectancy of at least 12 weeks * Pathologically confirmed diagnosis of metastatic colorectal cancer * Measureable disease * Have not received therapy for cancer within 4 weeks of enrollment on study * Prior radiation therapy to the pelvis for treatment of colorectal cancer is allowed. Radiation therapy delivered elsewhere is allowed as long as the patient has been off treatment for at least six weeks and measurable lesions are present outside the radiation field * Pretreatment granulocyte count of \> 1500/mm3, hemoglobin \> 9.0 g/dL (without transfusion), and platelet count of \> 100,000/um * Serum creatinine \< 2.0 mg/dL * Adequate hepatic function as documented by a serum bilirubin \< 2.0 mg/dL regardless of whether patients have liver involvement secondary to tumor. AST must be \< 3x the upper limit of normal unless the liver is involved with tumor, in which case the AST must be \< 5x institutional upper limit of normal Exclusion Criteria: * Prior therapy with Irinotecan * Patients with any active or uncontrolled infection * Patients with psychiatric disorders that would interfere with consent or follow-up * Patients with a history of myocardial infarction within the previous six months, congestive heart failure, or cerebrovascular disease * History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years * Presence of clinically apparent central nervous system metastases or carcinomatous meningitis * Patients with uncontrolled diabetes mellitus * Any other sever concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study * Patients unable to stop taking antihypertensive medication 24 hour prior to administration of Ethyol (off x 1 day)
References
Publications (0)
Data not yet available
No reference posted for this study.