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

Primary Purpose

Adenocarcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (arsenic trioxide)

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response (OR) defined as a complete or partial remission, evaluated using RECIST criteria

Secondary Outcome Measures

Duration of response
Toxicity graded according to the Common Toxicity Criteria version 2

Full Information

First Posted
June 5, 2003
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00061958
Brief Title
Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction
Official Title
A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (arsenic trioxide)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Other Intervention Name(s)
Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Objective response (OR) defined as a complete or partial remission, evaluated using RECIST criteria
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
Title
Toxicity graded according to the Common Toxicity Criteria version 2
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaffer Ajani
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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