Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

NCT ID: NCT00030862

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2003-12-31

Brief 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 combining irinotecan and cisplatin in treating patients who have locally advanced unresectable or metastatic cancer of the esophagus that has not been previously treated.

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.

Conditions

Esophageal Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

David H. Ilson, MD, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000069204

Identifier Type: REGISTRY

Identifier Source: secondary_id

PHARMACIA-440E-ONC-0020-319

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2050

Identifier Type: -

Identifier Source: secondary_id

01-123

Identifier Type: -

Identifier Source: org_study_id