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 10, 2013
Last verified: May 2013

July 5, 2008
May 10, 2013
October 2005
February 2014   (final data collection date for primary outcome measure)
Pathologic complete response [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
Pathologic complete response [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00711412 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • 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.
  • 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.
  • Experimental: Capecitabine, Oxaliplatin

    Weeks 1-6:

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

    Interventions:
    • Drug: Capecitabine - Induction Therapy
    • Drug: Oxaliplatin - Induction Therapy
  • Experimental: Capecitabine, Oxaliplatin, Radiation

    Weeks 7-12:

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

    Interventions:
    • Drug: Capcitabine - Combination Therapy
    • Drug: Oxaliplatin - Combination Therapy
    • Radiation: Radiation - Combination Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
February 2015
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00711412
NU 05I2, STU00006779
Yes
Northwestern University
Northwestern University
Not Provided
Principal Investigator: Mary Mulcahy, MD Robert H. Lurie Cancer Center
Northwestern University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP