Irinotecan in Treating Patients With Esophageal or Stomach Cancer (NCT00003748) | Clinical Trial Compass
CompletedPhase 2
Irinotecan in Treating Patients With Esophageal or Stomach Cancer
United States40 participantsStarted 1998-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 malign…
What they're measuring
1
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