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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077545
First received: February 10, 2004
Last updated: October 7, 2013
Last verified: October 2013

February 10, 2004
October 7, 2013
January 2004
March 2007   (final data collection date for primary outcome measure)
  • Complete response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Will be calculated together with 95% confidence intervals based on the binomial distribution.
  • Objective response rate (CR + PR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Will be calculated together with 95% confidence intervals based on the binomial distribution.
Not Provided
Complete list of historical versions of study NCT00077545 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be determined.
  • Progression-free survival [ Time Frame: From the start of treatment to progression or death, assessed up to 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be determined.
  • 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 ] [ Designated as safety issue: No ]
  • Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Number of patients with improvement of dysphagia [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Duration of improvement of dysphagia [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma of the Esophagus
  • Recurrent Esophageal Cancer
  • Stage IV Esophageal Cancer
  • Drug: triapine
    Given IV
  • Drug: cisplatin
    Given IV
Experimental: Treatment (triapine and 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.
Interventions:
  • Drug: triapine
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
Not Provided
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00077545
NCI-2012-02576, NCI-2012-02576, CDR0000352307, UCCRC-12765A, NCI-6285, 12765A, 6285, N01CM62201
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Ann Mauer University of Chicago Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP