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

Stage IV Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077545
• Other study ID #: NCI-2012-02576
• Secondary ID: NCI-2012-02576CD
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2004
• Last updated: October 7, 2013
• Start date: January 2004

Study information

• Verified date: October 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagus
• Esophageal Neoplasms
• Recurrent Esophageal Cancer
• Stage IV Esophageal Cancer

Intervention

Drug:
• triapine
Given IV
• cisplatin
Given IV

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate	Will be calculated together with 95% confidence intervals based on the binomial distribution.	Up to 2 years	No
Primary	Objective response rate (CR + PR)	Will be calculated together with 95% confidence intervals based on the binomial distribution.	Up to 2 years	No
Secondary	Overall survival	Kaplan-Meier estimates will be determined.	Up to 2 years	No
Secondary	Progression-free survival	Kaplan-Meier estimates will be determined.	From the start of treatment to progression or death, assessed up to 2 years	No
Secondary	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	No
Secondary	Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0		Up to 2 years	Yes
Secondary	Number of patients with improvement of dysphagia		Up to 2 years	No
Secondary	Duration of improvement of dysphagia		Up to 2 years	No