--- title: Irinotecan in Treating Patients With Esophageal or Stomach Cancer nct_id: NCT00003748 overall_status: COMPLETED phase: PHASE2 sponsor: Jonsson Comprehensive Cancer Center study_type: INTERVENTIONAL primary_condition: Esophageal Cancer countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00003748.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00003748" ct_last_update_post_date: 2020-08-03 last_seen_at: "2026-05-12T06:44:24.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Irinotecan in Treating Patients With Esophageal or Stomach Cancer **Official Title:** Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia **NCT ID:** [NCT00003748](https://clinicaltrials.gov/study/NCT00003748) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 40 - **Lead Sponsor:** Jonsson Comprehensive Cancer Center - **Collaborators:** Pharmacia and Upjohn - **Conditions:** Esophageal Cancer, Gastric Cancer - **Start Date:** 1998-08 - **Completion Date:** 2005-01 - **CT.gov Last Update:** 2020-08-03 ## Brief Summary 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. ## Detailed Description OBJECTIVES: I. Determine the antitumor activity of irinotecan in patients with adenocarcinoma of the esophagus or gastric cardia. II. Evaluate the toxicities of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive irinotecan intravenous (IV) over 90 minutes once a week for 4 weeks followed by a 2 week rest period. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **irinotecan hydrochloride** (EXPERIMENTAL) — 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. ## Interventions - **irinotecan hydrochloride** (DRUG) — 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. ## Primary Outcomes - **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** _(time frame: 2 years)_ ## Secondary Outcomes - **Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population** _(time frame: 2 years)_ ## Locations (25) - Comprehensive Blood and Cancer Center, Bakersfield, California, United States - St Jude Heritage Health Foundation, Fullerton, California, United States - Daniel Freeman Memorial Hospital, Inglewood, California, United States - UCLA - Antelope Valley Cancer Center, Lancaster, California, United States - Pacific Shores Medical Group, Long Beach, California, United States - Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States - Community Hospital of the Monterey Peninsula, Monterey, California, United States - Office of Jerome L. Rubin, Monterey, California, United States - Office of Eddie Hu, M.D., Monterey Park, California, United States - Ventura County Hematology-Oncology Medical Group, Inc., Oxnard, California, United States - Wilshire Oncology Medical Center, Pomona, California, United States - Salinas Valley Memorial Hospital, Salinas, California, United States - Cancer Center of Santa Barbara, Santa Barbara, California, United States - Sansum Medical Clinic, Santa Barbara, California, United States - James L. Poth, M.D., Michael Alexander, M.D., Inc., Santa Cruz, California, United States - Marian Medical Center, Santa Maria, California, United States - Office of Marilou Terpenning, Santa Monica, California, United States - Office of Robert C. Klein, Santa Monica, California, United States - Dominican and Watsonville Community Hospital, Soquel, California, United States - Los Robles Regional Medical Center, Thousand Oaks, California, United States - Cancer Care Associates Medical Group, Torrance, California, United States - UCLA Cancer Center - Santa Clarita, Valencia, California, United States - Oncology Medical Center of North County, Vista, California, United States - Valley Hematology and Oncology, West Hills, California, United States - Cancer Care Consultants, Las Vegas, Nevada, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.office of jerome l. rubin|monterey|california|united states` — added _(2026-05-12)_ - `locations.office of eddie hu, m.d.|monterey park|california|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.comprehensive blood and cancer center|bakersfield|california|united states` — added _(2026-05-12)_ - `locations.st jude heritage health foundation|fullerton|california|united states` — added _(2026-05-12)_ - `locations.daniel freeman memorial hospital|inglewood|california|united states` — added _(2026-05-12)_ - `locations.ucla - antelope valley cancer center|lancaster|california|united states` — added _(2026-05-12)_ - `locations.pacific shores medical group|long beach|california|united states` — added _(2026-05-12)_ - `locations.jonsson comprehensive cancer center, ucla|los angeles|california|united states` — added _(2026-05-12)_ - `locations.community hospital of the monterey peninsula|monterey|california|united states` — added _(2026-05-12)_ - `locations.ventura county hematology-oncology medical group, inc.|oxnard|california|united states` — added _(2026-05-12)_ - `locations.wilshire oncology medical center|pomona|california|united states` — added _(2026-05-12)_ - `locations.salinas valley memorial hospital|salinas|california|united states` — added _(2026-05-12)_ - `locations.cancer center of santa barbara|santa barbara|california|united states` — added _(2026-05-12)_ - `locations.sansum medical clinic|santa barbara|california|united states` — added _(2026-05-12)_ - `locations.james l. poth, m.d., michael alexander, m.d., inc.|santa cruz|california|united states` — added _(2026-05-12)_ - `locations.marian medical center|santa maria|california|united states` — added _(2026-05-12)_ - `locations.office of marilou terpenning|santa monica|california|united states` — added _(2026-05-12)_ - `locations.office of robert c. klein|santa monica|california|united states` — added _(2026-05-12)_ - `locations.dominican and watsonville community hospital|soquel|california|united states` — added _(2026-05-12)_ - `locations.los robles regional medical center|thousand oaks|california|united states` — added _(2026-05-12)_ - `locations.cancer care associates medical group|torrance|california|united states` — added _(2026-05-12)_ - `locations.ucla cancer center - santa clarita|valencia|california|united states` — added _(2026-05-12)_ - `locations.oncology medical center of north county|vista|california|united states` — added _(2026-05-12)_ - `locations.valley hematology and oncology|west hills|california|united states` — added _(2026-05-12)_ - `locations.cancer care consultants|las vegas|nevada|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00003748.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00003748* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*