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3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Primary Purpose

Adenocarcinoma of the Esophagus, Recurrent Esophageal Cancer, Stage IV Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
triapine
cisplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (triapine and cisplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

Complete response rate
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Objective response rate (CR + PR)
Will be calculated together with 95% confidence intervals based on the binomial distribution.

Secondary Outcome Measures

Overall survival
Kaplan-Meier estimates will be determined.
Progression-free survival
Kaplan-Meier estimates will be determined.
Duration of response
Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0
Number of patients with improvement of dysphagia
Duration of improvement of dysphagia

Full Information

First Posted
February 10, 2004
Last Updated
October 7, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077545
Brief Title
3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Official Title
A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help cisplatin kill more cancer cells by making them more sensitive to the drug. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Esophagus, Recurrent Esophageal Cancer, Stage IV Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (triapine and cisplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
triapine
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Complete response rate
Description
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Time Frame
Up to 2 years
Title
Objective response rate (CR + PR)
Description
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Kaplan-Meier estimates will be determined.
Time Frame
Up to 2 years
Title
Progression-free survival
Description
Kaplan-Meier estimates will be determined.
Time Frame
From the start of treatment to progression or death, assessed up to 2 years
Title
Duration of response
Time Frame
From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
Title
Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0
Time Frame
Up to 2 years
Title
Number of patients with improvement of dysphagia
Time Frame
Up to 2 years
Title
Duration of improvement of dysphagia
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Mauer
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

Learn more about this trial

3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction

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