Esophageal Cancer Clinical Trial

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.

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Full Description

OBJECTIVES:

Primary

Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabine, oxaliplatin, and radiotherapy.

Secondary

Determine the clinical response rate in patients treated with this regimen.
Determine the recurrence rate, time to progression, and patterns of failure in patients treated with this regimen.
Characterize the toxicity profile of this regimen in these patients.

OUTLINE:

Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease progression or unacceptable toxicity.
Surgery: Patients undergo surgical resection at 4-8 weeks after completion of chemoradiotherapy.

After completion of study treatment, patients are followed every 3 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction

Stage I-IVA disease
No distant metastatic disease (other than regional lymph nodes)

No evidence of CNS metastases

CNS metastases stable for > 3 months allowed

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Consuming ≥ 1,500 calories daily
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGOT ≤ 2.5 times ULN
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No pre-existing neuropathy
No prior unanticipated severe reaction to fluoropyrimidine therapy
No known hypersensitivity to fluorouracil
No known DPD deficiency
No known hypersensitivity to any of the components of oxaliplatin
No significant active infection or other severe complicated medical illness
No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication)
No myocardial infarction within the past 12 months
No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
No malabsorption syndrome
No other active malignancy within the past 3 years except cervical carcinoma in situ or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

More than 4 weeks since prior participation in any investigational drug study
No prior pelvic or thoracic radiotherapy

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT00711412

Recruitment Status:

Completed

Sponsor:

Northwestern University

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There is 1 Location for this study

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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT00711412

Recruitment Status:

Completed

Sponsor:


Northwestern University

How clear is this clinincal trial information?

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