Clinical trial · Interventional
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
NCT00077545CI-TRIAL-00012342completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Esophagus | Esophageal Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| triapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (triapine and cisplatin)
- description
- 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.
- interventionNames
- Drug: triapine
- Drug: cisplatin
Primary outcomes (2)
- measure
- Complete response rate
- timeFrame
- Up to 2 years
- description
- Will be calculated together with 95% confidence intervals based on the binomial distribution.
- measure
- Objective response rate (CR + PR)
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.