Full Text View
Tabular View
No Study Results Posted
Related Studies
3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
This study has been completed.
Study NCT00077545   Information provided by National Cancer Institute (NCI)
First Received: February 10, 2004   Last Updated: July 21, 2009   History of Changes

February 10, 2004
July 21, 2009
January 2004
July 2009   (final data collection date for primary outcome measure)
Objective response rate (complete and partial) [ Designated as safety issue: No ]
Objective response rate (complete and partial)
Complete list of historical versions of study NCT00077545 on ClinicalTrials.gov Archive Site
  • Duration of response [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Improvement in dysphagia [ Designated as safety issue: No ]
  • Duration of response
  • Progression-free survival
  • Overall survival
  • Toxicity
  • Improvement in dysphagia
 
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

RATIONALE: 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.

PURPOSE: 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.

OBJECTIVES:

Primary

  • 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

  • Determine the toxicity of this regimen in these patients.
  • Determine the duration of response and overall survival of patients treated with this regimen.
  • 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.

Phase II
Interventional
Treatment, Open Label
Esophageal Cancer
  • Drug: cisplatin
  • Drug: triapine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
July 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 50-100%

Life expectancy

  • More than 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • WBC ≥ 3,000/mm ^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal

Renal

  • Creatine normal OR
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • No prior myocardial infarction
  • No unstable angina
  • No cardiac arrhythmia
  • No uncontrolled congestive heart failure

Pulmonary

  • No pulmonary disease requiring supplemental oxygen

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 1 year since prior platinum-derivative agents
  • No prior chemotherapy for metastatic or recurrent esophageal cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • 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
 
CDR0000352307, UCCRC-12765A, NCI-6285
University of Chicago
National Cancer Institute (NCI)
Study Chair: Ann M. Mauer, MD University of Chicago
National Cancer Institute (NCI)
December 2005

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