A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
18 Years
N/A
Both
Adenocarcinoma of the Esophagus, Recurrent Esophageal Cancer, Stage IV Esophageal Cancer
Trial Information
A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
months.
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
participation
- 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:
Interventional
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:
No
Principal Investigator
Ann Mauer
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Chicago Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02576
NCT ID:
NCT00077545
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
Name | Location |
|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
