3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077545
First received: February 10, 2004
Last updated: December 21, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Esophagus Recurrent Esophageal Cancer Stage IV Esophageal Cancer |
Drug: triapine Drug: cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Complete response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Will be calculated together with 95% confidence intervals based on the binomial distribution.
- Objective response rate (CR + PR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Will be calculated together with 95% confidence intervals based on the binomial distribution.
Secondary Outcome Measures:
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Kaplan-Meier estimates will be determined.
- Progression-free survival [ Time Frame: From the start of treatment to progression or death, assessed up to 2 years ] [ Designated as safety issue: No ]Kaplan-Meier estimates will be determined.
- Duration of response [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
- Number of patients with improvement of dysphagia [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Duration of improvement of dysphagia [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 39 |
| Study Start Date: | January 2004 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
Drug: cisplatin
Given IV
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077545
Locations
| United States, Illinois | |
| University of Chicago Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60637-1470 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Ann Mauer | University of Chicago Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077545 History of Changes |
| Other Study ID Numbers: | NCI-2012-02576, 12765A, N01CM62201, CDR0000352307 |
| Study First Received: | February 10, 2004 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Esophageal Diseases Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Diseases Digestive System Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013