We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250835
First Posted: November 8, 2005
Last Update Posted: September 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
Results First Submitted: June 19, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Rectal Cancer
Intervention: Other: Chemotherapy, Celecoxib, and Radiation

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 )
First Submitted: November 4, 2005
First Posted: November 8, 2005
Results First Submitted: June 19, 2015
Results First Posted: September 1, 2015
Last Update Posted: September 1, 2015