Combination of Oxaliplatin, Capecitabine, and Celecoxib With Concurrent Radiation for Rectal Cancer

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00250835
First received: November 4, 2005
Last updated: August 3, 2015
Last verified: August 2015
Results First Received: June 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rectal Cancer
Intervention: Other: Chemotherapy, Celecoxib, and Radiation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from participating cancer clinics across the state of New Mexico

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Chemotherapy, Celecoxib, and Radiation

Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.

Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).

Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.

Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment.


Participant Flow:   Overall Study
    Chemotherapy, Celecoxib, and Radiation  
STARTED     38  
COMPLETED     37  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chemotherapy, Celecoxib, and Radiation

Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.

Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).

Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.

Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment.


Baseline Measures
    Chemotherapy, Celecoxib, and Radiation  
Number of Participants  
[units: participants]
  37  
Age  
[units: years]
Mean (Full Range)
  52  
  (20 to 69)  
Gender  
[units: participants]
 
Female     16  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     37  



  Outcome Measures
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1.  Primary:   Pathologic Complete Response (PCR)   [ Time Frame: At surgery (up to 6 weeks after end of treatment) ]

2.  Secondary:   Toxicity   [ Time Frame: Up to 3 years ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 3 years after surgery ]

4.  Secondary:   Incidence of Sphincter-sparing Surgery   [ Time Frame: At surgery (up to 6 weeks after end of treatment) ]

5.  Secondary:   Surgical Downstaging Rate   [ Time Frame: At surgery (up to 6 weeks after treatment) ]

6.  Secondary:   Pelvic Local Control Rate   [ Time Frame: Up to 3 years after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Fa-Chyi Lee, MD
Organization: University of New Mexico
phone: 5059250405
e-mail: flee@salud.unm.edu


Publications of Results:
W Murad, MH Fekrazad, R Schrader, BJ Liem, YZ Patt, FC Lee. A phase II trial of combination oxaliplatin, capecitabine, and celecoxib with concurrent radiation for patients with newly diagnosed resectable rectal cancer. J Clin Oncol 30:2012 (suppl 34; abstr 487)


Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00250835     History of Changes
Other Study ID Numbers: 3304C
NCI-2011-02685 ( Registry Identifier: NCI CTRP )
Study First Received: November 4, 2005
Results First Received: June 19, 2015
Last Updated: August 3, 2015
Health Authority: United States: Institutional Review Board