Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00470184
First received: May 3, 2007
Last updated: September 19, 2013
Last verified: September 2013
  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:


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 ]
  • Quality of Life Improved Rate [ Time Frame: 5.5 weeks ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: November 2006
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemo
Oxaliplatin 85 mg/m2 will be administered IV on days 1, 15 and 29. Capecitabine 1250 mg/m2 will be administered in 2 divided daily doses P0 or via enteral tube, on radiation days only (Monday- Friday/ weekly). Capecitabine will be continued until the final dose of radiotherapy
Drug: capecitabine
Oral
Drug: oxaliplatin
IV
Genetic: gene expression analysis
Correlative Study
Genetic: microarray analysis
Correlative Study
Genetic: reverse transcriptase-polymerase chain reaction
Correlative Study
Procedure: adjuvant therapy
Metastatic growth control
Procedure: biopsy
Examination of tissue type
Procedure: conventional surgery
Tissue removal
Procedure: neoadjuvant therapy
Tumor shrinkage
Procedure: quality-of-life assessment
Correlative Study
Radiation: radiation therapy
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Results First Received: September 19, 2013
Last Updated: September 19, 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 Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
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 August 27, 2014