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

Alternate Title

Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MDA-DM-02172 NCI-5647, NCT00061958, 5647

Objectives

1. Determine the response rate and duration of response in patients with advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with arsenic trioxide.
2. Determine the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
  • Metastatic or unresectable local-regional disease
  • Osseous metastasis as the only site of disease not eligible



• Measurable disease
  • Mediastinal or hilar lymph nodes must be at least 2.0 cm in diameter by CT scan or MRI to be considered measurable



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No prior immunotherapy (including adjuvant or preoperative regimens)
• No concurrent biological response modifiers
• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

• No prior chemotherapy (including adjuvant or preoperative regimens and radiosensitizers)

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to major bone marrow containing areas (e.g., pelvis or lumbar spine) or area that contained the indicator lesion
• No prior radiotherapy involving 30% or more of the bone marrow
• No concurrent radiotherapy

Surgery

• At least 2 weeks since prior major surgery (4 days for minor surgery) and recovered

Other

• No other concurrent investigational drugs
• No other concurrent antineoplastic therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 8 g/dL

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• SGOT and/or SGPT no greater than 2.0 times upper limit of normal (ULN)

Renal

• Creatinine no greater than 1.5 times ULN
• Creatinine clearance at least 60 mL/min
• Calcium no greater than 12 mg/dL
• No symptomatic hypercalcemia under treatment

Cardiovascular

• No New York Heart Association class III or IV heart disease
• No angina within the past 6 months
• No myocardial infarction within the past 6 months
• No congestive heart failure within the past 6 months

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Prior malignancies with no evidence of disease for at least 2 years are allowed
• No serious concurrent infection that is uncontrolled or whose control could be jeopardized by complications of study therapy
• No concurrent nonmalignant medical illness that is uncontrolled or whose control could be jeopardized by complications of study therapy
• No psychiatric disorder or other condition that would preclude study compliance

Expected Enrollment

A total of 17-50 patients will be accrued for this study.

Outline

This is an open-label study.

Patients receive a loading dose of arsenic trioxide IV over 2 hours on days 1-5 on week 1. Beginning on week 2, patients receive a maintenance dose of arsenic trioxide IV twice weekly thereafter. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) continue to receive therapy for at least 6 months beyond CR.

Patients are followed every 3 months for 6 months or until disease progression.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Jaffer Ajani, MD, Protocol chair		Ph: 713-792-2828; 800-392-1611 Email: jajani@mdanderson.org

Registry Information
Official Title		A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients with Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Trial Start Date		2003-06-26
Registered in ClinicalTrials.gov		NCT00061958 1
Date Submitted to PDQ		2003-04-11
Information Last Verified		2004-07-26
NCI Grant/Contract Number		N01-CM17003, P30-CA16672

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00061958