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A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Esophagus, Recurrent Esophageal Cancer, Stage IV Esophageal Cancer

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Trial Information

A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma


I. Determine the objective response rate in patients with recurrent or metastatic
adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine)
and cisplatin.


I. Determine the toxicity of this regimen in these patients. II. Determine the duration of
response and overall survival of patients treated with this regimen.

III. Determine the palliative benefits with regard to dysphagia in patients treated with
this regimen.

OUTLINE: This is a multicenter study.

Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive
cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every
21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 20

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the esophagus or
gastroesophageal junction

- Metastatic or recurrent disease

- Measurable disease

- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
OR ≥ 10 mm by spiral CT scan

- Outside prior irradiation port

- No known brain metastases

- Performance status - ECOG 0-2

- Performance status - Karnofsky 50-100%

- More than 6 months

- Absolute neutrophil count ≥ 1,500/mm^3

- WBC ≥ 3,000/mm ^3

- Platelet count ≥ 100,000/mm^3

- AST and ALT ≤ 2.5 times upper limit of normal

- Bilirubin normal

- Creatine normal

- Creatinine clearance ≥ 50 mL/min

- No prior myocardial infarction

- No unstable angina

- No cardiac arrhythmia

- No uncontrolled congestive heart failure

- No pulmonary disease requiring supplemental oxygen

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

- No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African,
Asian, or Mediterranean origin)

- No other concurrent uncontrolled illness

- No active or ongoing infection

- No active second malignancy

- No prior allergic reaction to compounds of similar chemical or biological composition
to 3-AP or other study agents

- No psychiatric illness or social situation that would preclude study compliance

- At least 1 year since prior platinum-derivative agents

- No prior chemotherapy for metastatic or recurrent esophageal cancer

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered

- No other concurrent anticancer therapy

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Outcome Description:

Will be calculated together with 95% confidence intervals based on the binomial distribution.

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Ann Mauer

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Esophagus
  • Recurrent Esophageal Cancer
  • Stage IV Esophageal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms



University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470