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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00061958
First received: June 5, 2003
Last updated: January 22, 2013
Last verified: January 2013
  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. Drugs used in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing so they stop growing or die


Condition Intervention Phase
Adenocarcinoma of the Esophagus
Stage III Esophageal Cancer
Stage IV Esophageal Cancer
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective response (OR) defined as a complete or partial remission, evaluated using RECIST criteria [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 months ] [ Designated as safety issue: No ]
  • Toxicity graded according to the Common Toxicity Criteria version 2 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: June 2003
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (arsenic trioxide)
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 CR continue to receive therapy for at least 6 months beyond CR.
Drug: arsenic trioxide
Given IV
Other Names:
  • Arsenic (III) Oxide
  • Arsenic Sesquioxide
  • Arsenous Acid Anhydride
  • AS2O3
  • Trisenox

Detailed Description:

OBJECTIVES:

I. Determine the response rate and duration of response in patients with advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with arsenic trioxide.

II. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Performance status - Zubrod 0-2
  • Performance status - Karnofsky 60-100%
  • At least 12 weeks
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 8 g/dL
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and/or SGPT no greater than 2.0 times upper limit of normal (ULN)
  • 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
  • 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
  • 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
  • No prior immunotherapy (including adjuvant or preoperative regimens)
  • No concurrent biological response modifiers
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No prior chemotherapy (including adjuvant or preoperative regimens and radiosensitizers)
  • 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
  • At least 2 weeks since prior major surgery (4 days for minor surgery) and recovered
  • No other concurrent investigational drugs
  • No other concurrent antineoplastic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061958

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Jaffer Ajani M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00061958     History of Changes
Other Study ID Numbers: NCI-2012-02534, DM02-172, N01CM17003, CDR0000302483
Study First Received: June 5, 2003
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014