PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.
OBJECTIVES: Primary: * Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan. Secondary: * Determine the time to treatment failure, time to overall response, duration of overall response, duration of overall complete response, and time to progression in patients treated with this regimen. * Determine the 1-year survival and overall survival of patients treated with this regimen. * Determine the toxicity and safety profile of this regimen in these patients. * Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (\>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.
Time frame: Approximately 43 Months
Time to Disease Progression
Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available.
Time frame: Approximately 43 Months
Time to Treatment Failure
Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent.
Time frame: Approximately 43 Months
Percentage of Participants With One-year Survival
Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.
Time frame: Up to Month 12
Overall Survival
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, United States
HemOnCare, P.C.
Brooklyn, New York, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, United States
...and 7 more locations
Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive.
Time frame: Approximately 43 Months
Time To Objective Response
The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response.
Time frame: Approximately 43 Months
Duration of Overall Response
Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment.
Time frame: Approximately 43 Months
Duration of Overall Complete Response
The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment.
Time frame: Approximately 43 Months
Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths
An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.
Time frame: Approximately 43 Months