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Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction
This study has been completed.
Study NCT00061958   Information provided by National Cancer Institute (NCI)
First Received: June 5, 2003   Last Updated: July 23, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 5, 2003
July 23, 2008
June 2003
 
 
Complete list of historical versions of study NCT00061958 on ClinicalTrials.gov Archive Site
 
 
 
Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction
A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction

RATIONALE: Drugs used in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic or unresectable cancer of the esophagus or gastroesophageal junction.

OBJECTIVES:

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

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.

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

Phase II
Interventional
Treatment, Open Label
Esophageal Cancer
Drug: arsenic trioxide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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

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/mm^3
  • Platelet count at least 100,000/mm^3
  • 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

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
Both
18 Years and older
No
 
United States
 
 
NCT00061958
 
MDA-DM-02172, NCI-5647
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Jaffer A. Ajani, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
July 2004

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.