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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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.


Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077545

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

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077545     History of Changes
Other Study ID Numbers: NCI-2012-02576, NCI-2012-02576, CDR0000352307, UCCRC-12765A, NCI-6285, 12765A, 6285, N01CM62201
Study First Received: February 10, 2004
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014