Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	UCCRC-12765A NCI-6285, NCT00077545, 6285

Objectives

Primary

1. 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

1. Determine the toxicity of this regimen in these patients.
2. Determine the duration of response and overall survival of patients treated with this regimen.
3. Determine the palliative benefits with regard to dysphagia in patients treated with this regimen.

Entry 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

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

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/mm³
• WBC ≥ 3,000/mm ³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 19-39 patients will be accrued for this study within 20 months.

Outcomes

Objective response rate (complete and partial)

Duration of response
Progression-free survival
Overall survival
Toxicity
Improvement in dysphagia

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.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Ann Mauer, MD, Protocol chair		Ph: 773-702-4138; 888-824-0200

Registry Information
Official Title		A Phase II Study Of Triapine® In Combination With Cisplatin Esophageal Carcinoma
Trial Start Date		2004-01-09
Trial Completion Date		2009-07-07
Registered in ClinicalTrials.gov		NCT00077545
Date Submitted to PDQ		2004-01-07
Information Last Verified		2005-12-30
NCI Grant/Contract Number		CM17102, CA14599

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