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

Phase 2

Completed

• Conditions: Adenocarcinoma of the Esophagus; Recurrent Esophageal Cancer; Stage IV Esophageal Cancer
• Interventions: Drug: triapine; Drug: cisplatin

• Registration Number: NCT00077545
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-11
• Study First Posted: 2004-02-12
• Primary Completion: 2007-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-07
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (triapine and cisplatin)	triapine	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.
Treatment (triapine and cisplatin)	cisplatin	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.

Primary Outcome Measures

Name	Time	Method
Objective response rate (CR + PR)	Up to 2 years	Will be calculated together with 95% confidence intervals based on the binomial distribution.
Complete response rate	Up to 2 years	Will be calculated together with 95% confidence intervals based on the binomial distribution.

Secondary Outcome Measures

Name	Time	Method
Number of patients with improvement of dysphagia	Up to 2 years
Overall survival	Up to 2 years	Kaplan-Meier estimates will be determined.
Duration of response	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
Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0	Up to 2 years
Progression-free survival	From the start of treatment to progression or death, assessed up to 2 years	Kaplan-Meier estimates will be determined.
Duration of improvement of dysphagia	Up to 2 years

Trial Locations

Locations (1)

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States