Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 7/20/2018 |
| Start Date: | May 31, 2006 |
| End Date: | January 30, 2013 |
A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
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.
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.
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.
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.
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
We found this trial at
1
site
675 N Saint Clair St # 21-100
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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