Overview

Cisplatin and Irinotecan in Treating Patients With Locally Advanced or Metastatic Esophageal or Gastric Cancer

Status:
Completed
Trial end date:
2001-04-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic esophageal or gastric cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Camptothecin
Cisplatin
Irinotecan
Criteria
DISEASE CHARACTERISTICS: Histologically proven locally advanced (surgically unresectable)
or metastatic squamous cell of the esophagus or carcinoma of the stomach Patients with
tumor extension below the GE junction into the proximal stomach must have the bulk of the
tumor involve the esophagus or GE junction Bidimensionally measurable or evaluable disease
No CNS metastases or carcinomatous meningitis No bone metastases (Closed to adenocarcinoma
of the esophagus as of 05/1998)

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Life
Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no
greater than 3 times upper limit of normal (ULN)(no greater than 5 times ULN if liver
metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No unstable
angina No New York Heart Association class III or IV cardiac disease Pulmonary: No
interstitial pulmonary fibrosis Other: Not pregnant or nursing Negative pregnancy test No
active or uncontrolled infection No prior malignancy for at least 5 years, except:
Nonmelanoma skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered No prior radiation to the pelvis Surgery: Not specified