- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030862
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
Phase II Single-Arm Trial Of CPT-11 (Irinotecan HC1; Camptosar Injection)/Cisplatin In Patients With Advanced Esophageal Cancer
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 combining irinotecan and cisplatin in treating patients who have locally advanced unresectable or metastatic cancer of the esophagus that has not been previously treated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the objective tumor response rate in patients with previously untreated locally advanced unresectable or metastatic esophageal cancer treated with irinotecan and cisplatin.
- Determine the dysphagia relief in patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1-2 hours and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus
- Previously untreated
- Locally advanced unresectable or metastatic disease
- More than 50% of tumor must involve esophagus or gastroesophageal (GE) junction if tumor extends below the GE junction into the proximal stomach
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusions
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions in previously irradiated areas
No carcinomatous meningitis or untreated brain metastases
- Brain metastases allowed if asymptomatic and patient is on stable or tapering dose of steroids
Large pleural effusions must have been previously drained and sclerosed or otherwise controlled
- Small, stable, asymptomatic pleural effusions allowed
- Dysphagia allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- No known Gilbert's disease
Renal:
- Creatinine no greater than 1.5 mg/dL
- Calcium less than 12.0 mg/dL
Cardiovascular:
- No history of significant cardiovascular disease
- No inadequately controlled hypertension
- No unstable angina
- No myocardial infarction within the past 6 months
- No ventricular cardiac arrhythmias requiring medication
- No history or treatment for congestive heart failure
Pulmonary:
- No interstitial pneumonia
- No fibroid lung
Other:
- No serious active infection
- No uncontrolled diabetes mellitus (random blood sugar at least 300 mg)
- No peripheral neuropathy grade 2 or greater
- No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy that does not carry a worse prognosis than advanced esophageal cancer
- No other serious underlying medical condition that would preclude study
- No other concurrent disease that would preclude study
- No psychiatric illness or other significant mental impairment that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy and recovered
- No prior radiotherapy to the pelvis
Surgery:
- See Disease Characteristics
- Not specified
Other:
- No concurrent phenytoin or phenobarbital
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: David H. Ilson, MD, PhD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- 01-123
- CDR0000069204 (Registry Identifier: PDQ (Physician Data Query))
- PHARMACIA-440E-ONC-0020-319
- NCI-G01-2050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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