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Phase II Trial of Cisplatin and Irinotecan in Patients With Advanced Esophageal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

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Trial Information

Phase II Trial of Cisplatin and Irinotecan in Patients With Advanced Esophageal Cancer


OBJECTIVES: I. Evaluate the response rate of combined cisplatin and irinotecan in patients
with metastatic or locally advanced (inoperable or recurrent) esophageal or gastric cancer.
II. Evaluate the toxic effects both qualitatively and quantitatively of cisplatin and
irinotecan in these patients. III. Estimate the disease free and overall survival of these
patients. IV. Assess whether the response proportion differs between squamous cell and
adenocarcinoma of the esophagus. V. Evaluate quality of life issues using the Memorial
Symptom Assessment Scale, the FACT-G questionnaire, and the dysphagia scale.

OUTLINE: Patients receive cisplatin and irinotecan on days 1, 8, 15, and 22 for 4 weeks,
followed by a 2 week rest period. Each treatment course lasts 6 weeks. Patients receive at
least 3 courses of therapy if the treatment is well tolerated and no disease progression is
documented. Patients attaining a complete response receive additional courses of therapy at
the discretion of the investigator. Tumor status is reassessed at 6 weeks and every 12 weeks
thereafter. Patients are followed until death.

PROJECTED ACCRUAL: A total of 28-50 patients will be accrued within 12-18 months. Accrual
for adenocarcinoma of the esophagus is complete.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David H. Ilson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

97-060

NCT ID:

NCT00003055

Start Date:

June 1997

Completion Date:

April 2001

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • squamous cell carcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021