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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02576 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000352307 | |||
| UCCRC-12765A | |||
| NCI-6285 | |||
| 12765A | Other Identifier | University of Chicago Comprehensive Cancer Center | |
| 6285 | Other Identifier | CTEP | |
| N01CM62201 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (triapine and cisplatin) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triapine | Drug | Given IV |
| |
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Will be calculated together with 95% confidence intervals based on the binomial distribution. | Up to 2 years |
| Objective response rate (CR + PR) | Will be calculated together with 95% confidence intervals based on the binomial distribution. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Kaplan-Meier estimates will be determined. | Up to 2 years |
| Progression-free survival | Kaplan-Meier estimates will be determined. |
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Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
Measurable disease
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
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| Name | Affiliation | Role |
|---|---|---|
| Ann Mauer | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637-1470 | United States |
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| Drug |
Given IV |
|
| From the start of treatment to progression or death, assessed up to 2 years |
| 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 |
| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C078157 | 3-aminopyridine-2-carboxaldehyde thiosemicarbazone |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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