Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer
18 Years
N/A
Both
Esophageal Cancer
Trial Information
Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer
OBJECTIVES:
Primary
- Determine the complete pathologic response (complete response [CR]) rate in patients
with stage II-IVA esophageal cancer treated with neoadjuvant oxaliplatin, capecitabine,
and radiotherapy.
Secondary
- Determine the clinical efficacy and toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
- Identify basal expression and changes in gene expression that relate to CR, relapse,
and survival of patients treated with this regimen.
OUTLINE:
- Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1,
15, and 29 (weeks 1, 3, and 5). Patients also undergo radiotherapy on days 1-5, 8-12,
15-19, 22-26, 29-33, and 36-38 and receive oral or enteral capecitabine twice daily on
the same days they undergo radiotherapy.
- Surgery: At 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients who
are eligible undergo esophagectomy.
- Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive oxaliplatin
IV over 2 hours on days 1, 15, and 29 and oral or enteral capecitabine twice daily on
days 1-5, 8-12, 15-19, 22-26, and 29. Treatment repeats approximately every 14 days for
up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor biopsies periodically. Collected samples are analyzed by gene
expression studies, microarray analysis, and real-time quantitative reverse
transcriptase-PCR to identify basal expression and changes in gene expression.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the
esophagus
- Stage II-IVA disease as determined by clinical staging, including endoscopy and
CT scan with or without endoscopic ultrasound
- Bulk of gastroesophageal junction tumor should be in the esophagus
- Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26
cm from incisors
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 4 months
- WBC > 4,000/mm³
- ANC > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 9 g/dL
- Bilirubin normal
- Creatinine normal
- AST < 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Able to take oral medication or undergo enteral administration of medication
- No peripheral neuropathy ≥ grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 90 days after
completion of study treatment
- No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics
administered in combination with protocol-directed chemotherapy
- No concurrent uncontrolled illness, including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would preclude study compliance
- No history of second malignancy except for curatively treated carcinoma in situ of
the cervix or nonmelanoma skin cancer
- Other cured tumors allowed at discretion of the principal investigator
- No known HIV or hepatitis B or C (active and/or previously treated)
PRIOR CONCURRENT THERAPY:
- No prior therapy for esophageal cancer
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response
Outcome Time Frame:
5.5 weeks
Safety Issue:
No
Principal Investigator
Nikhil Khushalani, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000543376
NCT ID:
NCT00470184
Start Date:
November 2006
Completion Date:
Related Keywords:
- Esophageal Cancer
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- stage II esophageal cancer
- stage III esophageal cancer
- stage IV esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
