Clinical trial · Interventional
Irinotecan in Treating Patients With Esophageal or Stomach Cancer
Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia
NCT00003748CI-TRIAL-00046365completedPhase 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 II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinotecan hydrochloride
- description
- One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks.
- interventionNames
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- To determine the antitumor activity of irinotecan hydrochloride (CPT-11) in patients with unresectable adenocarcinoma of the esophagus and gastric cardia who have failed prior chemotherapy
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be \> 18 years of age * Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale * Patients must have a predicted life expectancy of at least 12 weeks * Patients must have a pretreatment granulocyte count of \>1500/mm3, a hemoglobin level of \>9.0 gm/dL and the platelet count of \>100000/mm3 * Patients must have adequate renal function as documented by a serum creatinine \< 2.0 mg/dL * Patients must have adequate hepatic function as documented by a serum bilirubin \< 1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase must be \< 3 x institutional upper limit of normal unless the liver is involved with tumor, in which case the aspartate transaminase must be \< 5 x institutional upper limit of normal * Patients must have histologically proven adenocarcinoma of the esophagus or gastric cardia with progression despite prior chemotherapy * Patients must have disease radiologically measurable bidimensionally * Patients must have an interval of 4 weeks from prior chemotherapy, immunotherapy, or radiation therapy Exclusion Criteria: * 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 or congestive heart failure requiring therapy * Patients with a 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 * Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Presence of clinically apparent central nervous system metastases or carcinomatous meningitis * Patients with uncontrolled diabetes mellitus * Patients with any other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study * Prior therapy with a deoxyribonucleic acid (DNA) topoisomerase inhibitor * Patients with known Gilbert's syndrome
References
Publications (0)
Data not yet available
No reference posted for this study.