A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic complete response
Outcome Time Frame:
At time of surgery
Safety Issue:
No
Principal Investigator
Mary Mulcahy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 05I2
NCT ID:
NCT00711412
Start Date:
October 2005
Completion Date:
February 2015
Related Keywords:
- Esophageal Cancer
- adenocarcinoma of the esophagus
- stage I esophageal cancer
- stage II esophageal cancer
- stage III esophageal cancer
- stage IV esophageal cancer
- Adenocarcinoma
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
