3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
-
Determine the toxicity of this regimen in these patients. II. Determine the duration of response and overall survival of patients treated with this regimen.
-
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (triapine and cisplatin) 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. |
Drug: triapine
Given IV
Drug: cisplatin
Given IV
|
Outcome Measures
Primary Outcome Measures
- Complete response rate [Up to 2 years]
Will be calculated together with 95% confidence intervals based on the binomial distribution.
- Objective response rate (CR + PR) [Up to 2 years]
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Secondary Outcome Measures
- Overall survival [Up to 2 years]
Kaplan-Meier estimates will be determined.
- Progression-free survival [From the start of treatment to progression or death, assessed up to 2 years]
Kaplan-Meier estimates will be determined.
- Duration of response [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]
- Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0 [Up to 2 years]
- Number of patients with improvement of dysphagia [Up to 2 years]
- Duration of improvement of dysphagia [Up to 2 years]
Eligibility Criteria
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)
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No other concurrent uncontrolled illness
-
No active or ongoing infection
-
No active second malignancy
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No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP or other study agents
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No psychiatric illness or social situation that would preclude study compliance
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At least 1 year since prior platinum-derivative agents
-
No prior chemotherapy for metastatic or recurrent esophageal cancer
-
See Disease Characteristics
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637-1470 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ann Mauer, University of Chicago Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-02576
- NCI-2012-02576
- CDR0000352307
- UCCRC-12765A
- NCI-6285
- 12765A
- 6285
- N01CM62201