3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal
Junction
This study is currently recruiting patients.
Sponsored by: |
University of Chicago Cancer Research Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
RATIONALE: 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.
PURPOSE: Phase II trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have recurrent
or metastatic adenocarcinoma of the esophagus or gastroesophageal junction.
Condition
|
Treatment or Intervention |
Phase |
recurrent esophageal cancer stage IV esophageal cancer Adenocarcinoma of the Esophagus
|
Drug: 3-AP Drug: cisplatin Procedure: chemosensitization/potentiation Procedure: chemotherapy
|
Phase II
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Esophageal Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 3-AP (Triapine®) and Cisplatin in Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus
or Gastroesophageal Junction
Further Study Details:
OBJECTIVES: Primary
- 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
- Determine the toxicity of this regimen in these patients.
- 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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS: Age
Performance status
- ECOG 0-2 OR
- Karnofsky 50-100%
Life expectancy
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- WBC ≥ 3,000/mm ^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin normal
Renal
- Creatine normal OR
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- No prior myocardial infarction
- No unstable angina
- No cardiac arrhythmia
- No uncontrolled congestive heart failure
Pulmonary
- No pulmonary disease requiring supplemental oxygen
Other
- 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
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
- At least 1 year since prior platinum-derivative agents
- No prior chemotherapy for metastatic or recurrent esophageal cancer
Endocrine therapy
Radiotherapy
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy and recovered
Surgery
Other
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Location
and Contact
Information
Illinois Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,
Illinois,
60153,
United States; Recruiting
Ellen R. Gaynor, MD
708-327-3101
Central Illinois Hematology Oncology Center, Springfield,
Illinois,
62701,
United States; Recruiting
Decatur Memorial Hospital Cancer Care Institute, Decatur,
Illinois,
62526,
United States; Recruiting
James L. Wade, MD
217-876-6603
Indiana Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,
Indiana,
46885-5099,
United States; Recruiting
David Frank Sciortino, MD
219-484-8830
Wisconsin Medical College of Wisconsin Cancer Center, Milwaukee,
Wisconsin,
53226,
United States; Recruiting
Stuart J. Wong, MD
414-805-4603
Study chairs or principal investigators
Ann M. Mauer, MD, Study Chair, University of Chicago Cancer Research Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000352307; UCCRC-12765A; NCI-6285
Record last reviewed:
October 2004
Record first received:
February 10, 2004
ClinicalTrials.gov Identifier:
NCT00077545Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-16