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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cisplatin

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