Oxaliplatin, Capecitabine, and Radiation Therapy in Treating Patients Undergoing Surgery for Stage II, Stage III, or Stage IV Esophageal Cancer - Full Text View

Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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 together with 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 oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal cancer.

Condition	Intervention	Phase
Esophageal Cancer	Drug: capecitabine Drug: oxaliplatin Genetic: gene expression analysis Genetic: microarray analysis Genetic: reverse transcriptase-polymerase chain reaction Procedure: adjuvant therapy Procedure: biopsy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Oxaliplatin Capecitabine

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

Complete response [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate (complete and partial response) as measured by RECIST criteria after course 1 [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]
Median time to progression [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: 5.5 weeks ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]
Gene expression [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	November 2006
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Oral

IV

Correlative Study

Metastatic growth control

Examination of tissue type

Tissue removal

Tumor shrinkage

Correlative Study

Undergoing radiation therapy

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470184

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

National Comprehensive Cancer Network

Investigators

Principal Investigator:

Nikhil Khushalani, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00470184 History of Changes
Other Study ID Numbers:	CDR0000543376, RPCI-I-64105
Study First Received:	May 3, 2007
Last Updated:	April 23, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Oxaliplatin
Capecitabine

Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013