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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Stage IV Esophageal Cancer

Recurrent Esophageal Cancer

Adenocarcinoma of the Esophagus

Treatments

Drug: cisplatin

Drug: triapine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00077545

NCI-6285

6285 (Other Identifier)

UCCRC-12765A

NCI-2012-02576 (Registry Identifier)

CDR0000352307

12765A (Other Identifier)

N01CM62201 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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