Esophageal Cancer, Gastric Cancer
Conditions
Keywords
stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
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.
Interventions
DRUGirinotecan hydrochloride
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.
Sponsors
Pharmacia and Upjohn
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population | 2 years |
Countries
United States
Outcome results
None listed