3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Esophagus, Recurrent Esophageal Cancer, Stage IV Esophageal Cancer
In brief
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.
Key facts
- Study ID
- NCT00077545
- Run by
- National Cancer Institute (NCI)
- People needed
- 39
- Starts
- 2004-01-01
- Last updated by the study team
- 2013-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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)
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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