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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00077545
First Posted: February 12, 2004
Last Update Posted: October 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Adenocarcinoma of the Esophagus Recurrent Esophageal Cancer Stage IV Esophageal Cancer Drug: triapine Drug: cisplatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response rate [ Time Frame: Up to 2 years ]
    Will be calculated together with 95% confidence intervals based on the binomial distribution.

  • Objective response rate (CR + PR) [ Time Frame: Up to 2 years ]
    Will be calculated together with 95% confidence intervals based on the binomial distribution.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 2 years ]
    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 ]
    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 ]
  • Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 2 years ]
  • Number of patients with improvement of dysphagia [ Time Frame: Up to 2 years ]
  • Duration of improvement of dysphagia [ Time Frame: Up to 2 years ]

Estimated Enrollment: 39
Study Start Date: January 2004
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: triapine
Given IV
Drug: cisplatin
Given IV

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077545


Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ann Mauer University of Chicago Comprehensive Cancer Center
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077545     History of Changes
Other Study ID Numbers: NCI-2012-02576
NCI-2012-02576 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000352307
UCCRC-12765A
NCI-6285
12765A ( Other Identifier: University of Chicago Comprehensive Cancer Center )
6285 ( Other Identifier: CTEP )
N01CM62201 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2004
First Posted: February 12, 2004
Last Update Posted: October 8, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Antineoplastic Agents