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



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

For Condition: Adenocarcinoma of the Esophagus,stage 4 esophageal cancer,stage 3 esophageal cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have metastatic or unresectable cancer of the esophagus or gastroesophageal junction.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JafferAjani,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Jaffer  Ajani 713-792-2828


Additional Information:
Study ID Numbers:  CDR0000302483;  MDA-DM-02172,NCI-5647
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061958

Other Stage 4 Esophageal Cancer Studies:
1. PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus

2. Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus

3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

4. DX-8951f in Treating Patients With Metastatic Stomach Cancer

5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus

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