Clinical trial NCT00077545: 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Official title: A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Esophagus
Recurrent Esophageal Cancer
Stage IV Esophageal Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-02-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Complete response rate
timeFrame: Up to 2 years
measure: Objective response rate (CR + PR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 2 years
measure: Progression-free survival
timeFrame: From the start of treatment to progression or death, assessed up to 2 years
measure: Duration of response
timeFrame: 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
measure: Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0
timeFrame: Up to 2 years
measure: Number of patients with improvement of dysphagia
timeFrame: Up to 2 years
measure: Duration of improvement of dysphagia
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Ann Mauer
role: PRINCIPAL_INVESTIGATOR
References: