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

Northwestern University

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer

Treatments: Drug: Induction Therapy - Oxaliplatin; Procedure: Evaluation for response and surgery; Drug: Combination Therapy - Capecitabine; Drug: Combination Therapy - Oxaliplatin; Drug: Induction Therapy - Capecitabine; Radiation: Combination Therapy - Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00711412

NU 05I2

STU00006779 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Induction, Combination and surgery

Experimental group

Description:

Weeks 1-6: Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8 Weeks 7-12: Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday Evaluation for response and resection surgery

Treatment:

Drug: Induction Therapy - Capecitabine

Procedure: Evaluation for response and surgery

Drug: Combination Therapy - Capecitabine

Drug: Induction Therapy - Oxaliplatin

Drug: Combination Therapy - Oxaliplatin

Radiation: Combination Therapy - Radiation