We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer (ADAPT)

This study has been terminated.
(Funding ended)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01729923
First Posted: November 20, 2012
Last Update Posted: December 1, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stacey Cohen, University of Washington
Results First Submitted: September 5, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Colon Carcinoma
Recurrent Rectal Carcinoma
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions: Drug: Capecitabine
Drug: Celecoxib
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Radiation: Stereotactic Radiosurgery
Procedure: Therapeutic Conventional Surgery

  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
This study was activated on March 30, 2013 and terminated on August 12, 2016 due to lack of funding and prior to reaching its enrollment goal. A total 27 participants were accrued.

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
Treatment (Capecitabine, Celecoxib, Radiation Therapy)

Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.

RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.

ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Celecoxib: Given PO

Intensity-Modulated Radiation Therapy: Undergo IMRT

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Radiation Therapy: Undergo radiation therapy

Stereotactic Radiosurgery: Undergo stereotactic radiosurgery

Therapeutic Conventional Surgery: Undergo surgical resection


Participant Flow:   Overall Study
    Treatment (Capecitabine, Celecoxib, Radiation Therapy)
STARTED   27 
COMPLETED   0 
NOT COMPLETED   27 



  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
Treatment (Capecitabine, Celecoxib, Radiation Therapy)

Patients proceed to surgery, radiation therapy with ADAPT therapy followed by maintenance ADAPT therapy, or ADAPT therapy. Eligible patients undergo surgical resection at baseline or upon achievement of resectable disease after radiation therapy.

RADIATION + ADAPT: Patients undergo radiation therapy 5 days per week and receive capecitabine PO BID and celecoxib PO BID 5 days per week during radiation.

ADAPT: Patients receive capecitabine PO BID on days 1-14 and celecoxib PO BID on days 1-21. Courses repeat every 21 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Celecoxib: Given PO

Intensity-Modulated Radiation Therapy: Undergo IMRT

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Radiation Therapy: Undergo radiation therapy

Stereotactic Radiosurgery: Undergo stereotactic radiosurgery

Therapeutic Conventional Surgery: Undergo surgical resection


Baseline Measures
   Treatment (Capecitabine, Celecoxib, Radiation Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      24  88.9% 
>=65 years      3  11.1% 
Age 
[Units: Years]
Median (Full Range)
 46 
 (30 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  44.4% 
Male      15  55.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   27 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1   [ Time Frame: 3 years ]

2.  Secondary:   Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion   [ Time Frame: Serial measures at 9 week intervals up to 5 years ]

3.  Secondary:   Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy   [ Time Frame: Serial measures at 9 week intervals up to 5 years ]

4.  Secondary:   K-ras Mutation Status   [ Time Frame: Up to 5 years ]

5.  Secondary:   Overall Survival   [ Time Frame: Until death or last reported survival, up to 5 years ]

6.  Secondary:   Quality of Life (QOL), Assessed Using the M.D. Anderson Symptom Inventory (MDASI)   [ Time Frame: Up to 5 years ]

7.  Secondary:   Relapse Free Survival in Patients Achieving CR   [ Time Frame: Up to 5 years ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Stacey Cohen, Principal Investigator
Organization: University of Washington
phone: 206-606-6658
e-mail: shiovitz@uw.edu



Responsible Party: Stacey Cohen, University of Washington
ClinicalTrials.gov Identifier: NCT01729923     History of Changes
Other Study ID Numbers: 7707
NCI-2012-02137 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
7707 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: November 15, 2012
First Posted: November 20, 2012
Results First Submitted: September 5, 2017
Results First Posted: December 1, 2017
Last Update Posted: December 1, 2017