A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
triapine
+ cisplatin
Adenocarcinoma+10
+ Carcinoma
+ Digestive System Diseases
Treatment Study
Summary
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.39 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location