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Phase II Single-Arm Trial Of CPT-11 (Irinotecan HC1; Camptosar Injection)/Cisplatin In Patients With Advanced Esophageal Cancer


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

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Trial Information

Phase II Single-Arm Trial Of CPT-11 (Irinotecan HC1; Camptosar Injection)/Cisplatin In Patients With Advanced Esophageal Cancer


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.

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

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:

01-123

NCT ID:

NCT00030862

Start Date:

October 2001

Completion Date:

December 2003

Related Keywords:

  • Esophageal Cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021