Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00711412
First received: July 5, 2008
Last updated: May 12, 2014
Last verified: May 2014
  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 - Induction Therapy
Drug: Oxaliplatin - Induction Therapy
Drug: Capcitabine - Combination Therapy
Drug: Oxaliplatin - Combination Therapy
Radiation: Radiation - Combination Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Pathologic complete response [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response rate [ Time Frame: Following chemotherapy treatment and prior to surgery ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: At the time of disease recurrence or death ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: At the time of progression of disease ] [ Designated as safety issue: No ]
  • Patterns of failure [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: During chemotherapy and up to 30 days post-last dose of chemotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: October 2005
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine, Oxaliplatin

Weeks 1-6:

Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8

Drug: Capecitabine - Induction Therapy
Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Drug: Oxaliplatin - Induction Therapy
Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.
Experimental: Capecitabine, Oxaliplatin, Radiation

Weeks 7-12:

Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday

Drug: Capcitabine - Combination Therapy
Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Drug: Oxaliplatin - Combination Therapy
Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Radiation: Radiation - Combination Therapy
1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.

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
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: NCT00711412

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Mary Mulcahy, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00711412     History of Changes
Other Study ID Numbers: NU 05I2, STU00006779
Study First Received: July 5, 2008
Last Updated: May 12, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Northwestern University:
adenocarcinoma of the esophagus
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
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 July 23, 2014