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Trial record 49 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

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

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.
 
ClinicalTrials.gov Identifier: NCT01729923
Recruitment Status : Terminated (Funding ended)
First Posted : November 20, 2012
Results First Posted : December 2, 2017
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stacey Cohen, University of Washington

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
Enrollment 27
Recruitment Details 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  
Arm/Group Title Treatment (Capecitabine, Celecoxib, Radiation Therapy)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 27
Completed 0
Not Completed 27
Arm/Group Title Treatment (Capecitabine, Celecoxib, Radiation Therapy)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  88.9%
>=65 years
3
  11.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
46
(30 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
12
  44.4%
Male
15
  55.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
 100.0%
1.Primary Outcome
Title Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Hide Description Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level in response to ADAPT therapy.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine and Celecoxib
Hide Arm/Group Description:
Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.7%
2.Secondary Outcome
Title Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion
Hide Description RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.
Time Frame Serial measures at 9 week intervals up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had RECIST measures at baseline and at least one other time point.
Arm/Group Title Capecitabine and Celecoxib
Hide Arm/Group Description:
Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
Overall Number of Participants Analyzed 19
Mean (Full Range)
Unit of Measure: percentage of baseline lesion size
-17
(-100 to 75.6)
3.Secondary Outcome
Title 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
Hide Description RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.
Time Frame Serial measures at 9 week intervals up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had RECIST measurements at baseline and at least one subsequent occasion and did not have surgery or radiation therapy
Arm/Group Title Capecitabine and Celecoxib
Hide Arm/Group Description:
Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
Overall Number of Participants Analyzed 8
Mean (Full Range)
Unit of Measure: percentage of baseline lesion size
11
(-31.2 to 75.6)
4.Secondary Outcome
Title K-ras Mutation Status
Hide Description The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
K-ras mutation status was not collected.
Arm/Group Title Capecitabine and Celecoxib
Hide Arm/Group Description:
Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation until death or last reported survival.
Time Frame Until death or last reported survival, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine and Celecoxib
Hide Arm/Group Description:
Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
Overall Number of Participants Analyzed 27
Median (Full Range)
Unit of Measure: months
15
(2 to 30)
6.Secondary Outcome
Title Quality of Life (QOL), Assessed Using the M.D. Anderson Symptom Inventory (MDASI)
Hide Description Group differences in QOL will be estimated, with repeated measures used to improve precision of estimates.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
We have been unable to confirmation that the original Principal Investigator secured the appropriate permission to use this instrument. Therefore, we are unable to use the data.
Arm/Group Title Capecitabine and Celecoxib
Hide Arm/Group Description:
Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Relapse Free Survival in Patients Achieving CR
Hide Description Relapse-free survival estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Measure Description: Inclusive of subject still alive at time of last reporting Time Frame: Until last reported survival Study terminated; data not further analyzed
Arm/Group Title Capecitabine and Celecoxib
Hide Arm/Group Description:
Patients are treated with oral capecitabine and celecoxib twice daily 7 days per week. Radiation therapy may be used for selected patients. During radiation, treatment with oral capecitabine and celecoxib will be given twice daily 5 days per week. Surgery may also be used for selected patients.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: months
7
Time Frame 3 years
Adverse Event Reporting Description The adverse event recording period will start on the first day of study treatment and end 30 days after last protocol required treatment is administered. Only grade 2 and higher AEs will be recorded with the exception of any AE that requires a dose reduction or treatment interruption.
 
Arm/Group Title Treatment (Capecitabine, Celecoxib, Radiation Therapy)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Capecitabine, Celecoxib, Radiation Therapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Capecitabine, Celecoxib, Radiation Therapy)
Affected / at Risk (%) # Events
Total   1/27 (3.70%)    
Gastrointestinal disorders   
Nonoliguric Renal Failure * 1  1/27 (3.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Capecitabine, Celecoxib, Radiation Therapy)
Affected / at Risk (%) # Events
Total   18/27 (66.67%)    
Gastrointestinal disorders   
Diarrhea * 1  3/27 (11.11%) 
Post-Operative Pain * 1  2/27 (7.41%) 
Abdominal Pain * 1  2/27 (7.41%) 
General disorders   
Fatigue * 1  4/27 (14.81%) 
Immune system disorders   
Lupus (autoimmune reaction) * 1  2/27 (7.41%) 
Skin and subcutaneous tissue disorders   
Hand/Foot Syndrome * 1  13/27 (48.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 3.0
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
Layout table for Results Point of Contact information
Name/Title: Dr. Stacey Cohen, Principal Investigator
Organization: University of Washington
Phone: 206-606-6658
EMail: shiovitz@uw.edu
Layout table for additonal information
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 2, 2017
Last Update Posted: January 16, 2018