3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction - Full Text View

Sponsor:	University of Chicago
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077545

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: 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
Esophageal Cancer	Drug: cisplatin Drug: triapine	Phase II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Objective response rate (complete and partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Improvement in dysphagia [ Designated as safety issue: No ]

Study Start Date:	January 2004
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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 older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

18 and over

Performance status

ECOG 0-2 OR
Karnofsky 50-100%

Life expectancy

More than 6 months

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

Not specified

Chemotherapy

At least 1 year since prior platinum-derivative agents
No prior chemotherapy for metastatic or recurrent esophageal cancer

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
At least 2 weeks since prior radiotherapy and recovered

Surgery

Not specified

Other

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
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701

Sponsors and Collaborators

University of Chicago

National Cancer Institute (NCI)

Investigators

Study Chair:

Ann M. Mauer, MD

University of Chicago

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000352307, UCCRC-12765A, NCI-6285
Study First Received:	February 10, 2004
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00077545 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent esophageal cancer
stage IV esophageal cancer
adenocarcinoma of the esophagus

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases

Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on March 18, 2010