Know Cancer

or
forgot password

A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer

Thank you

Trial Information

A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Jaffer Ajani

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02534

NCT ID:

NCT00061958

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Esophagus
  • Stage III Esophageal Cancer
  • Stage IV Esophageal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030