NCT00077545

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

3.2 years

First QC Date

February 10, 2004

Last Update Submit

October 7, 2013

Conditions

Adenocarcinoma of the EsophagusRecurrent Esophageal CancerStage IV Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • Complete response rate

    Will be calculated together with 95% confidence intervals based on the binomial distribution.

    Up to 2 years

  • Objective response rate (CR + PR)

    Will be calculated together with 95% confidence intervals based on the binomial distribution.

    Up to 2 years

Secondary Outcomes (6)

  • Overall survival

    Up to 2 years

  • Progression-free survival

    From the start of treatment to progression or death, assessed up to 2 years

  • 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

  • Number of patients with improvement of dysphagia

    Up to 2 years

  • +1 more secondary outcomes

Study Arms (1)

Treatment (triapine and cisplatin)

EXPERIMENTAL

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: triapineDrug: cisplatin

Interventions

triapineDRUG

Given IV

Treatment (triapine and cisplatin)
cisplatinDRUG

Given IV

Treatment (triapine and cisplatin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of EsophagusEsophageal Neoplasms

Interventions

3-aminopyridine-2-carboxaldehyde thiosemicarbazoneCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Ann Mauer

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 12, 2004

Study Start

January 1, 2004

Primary Completion

March 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)