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

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

Study Overview

• Status: Terminated
• Conditions: Adenocarcinoma of the Esophagus; Stage IV Esophageal Cancer; Stage III Esophageal Cancer
• Intervention / Treatment: Drug: arsenic trioxide

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response (OR) defined as a complete or partial remission, evaluated using RECIST criteria	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of response	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
Toxicity graded according to the Common Toxicity Criteria version 2	Up to 6 months

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jaffer Ajani, M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: June 5, 2003
• First Submitted That Met QC Criteria: June 5, 2003
• First Posted (Estimate): June 6, 2003

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms; Antineoplastic Agents; Arsenic Trioxide
• Other Study ID Numbers: NCI-2012-02534; N01CM17003 (U.S. NIH Grant/Contract); DM02-172; CDR0000302483 (Registry Identifier: PDQ (Physician Data Query))