Full Text View
Tabular View
No Study Results Posted
Related Studies
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
First Received: July 5, 2008   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00711412
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: capecitabine
Drug: oxaliplatin
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Radiation Therapy Surgery
Drug Information available for: Oxaliplatin Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathologic complete response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response rate [ Designated as safety issue: No ]
  • Recurrence rate [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Patterns of failure [ Designated as safety issue: No ]
  • Toxicity profile [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: October 2005
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711412

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Principal Investigator: Mary Mulcahy, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Mary Mulcahy )
Study ID Numbers: CDR0000599730, NU-0512, NU-IRB-0948-009
Study First Received: July 5, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00711412     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Study placed in the following topic categories:
Antimetabolites
Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Oxaliplatin
Digestive System Diseases
Esophageal Disorder
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Pharmacologic Actions
Neoplasms
Oxaliplatin
Digestive System Diseases
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009