A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069108
• Other study ID #: NO16967
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2003
• Last updated: January 27, 2016
• Start date: July 2003
• Est. completion date: August 2006

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 627
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• metastatic colorectal cancer;

• >=1 target lesion;

• failed first-line chemotherapy with 5-fluorouracil and irinotecan.

Exclusion Criteria:

• previous treatment with oxaliplatin;

• progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;

• >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 5 FU
As prescribed, in 2 week cycles
• Leucovorin
As prescribed, in 2 week cycles
• Oxaliplatin
As prescribed, in 3 week cycles
• Oxaliplatin
As prescribed, in 2 week cycles
• capecitabine [Xeloda]
1000mg/m2 po bid on days 1-15 of each 3 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Croatia,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Korea, Republic of,  Poland,  Puerto Rico,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	Progression free survival was defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at date of randomization	Up to 3 years	No
Secondary	Progression Free Survival Based on Independent Review Committee (IRC) Assessment	Progression free survival was defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria and was based on IRC assessment	Up to 3 years	No
Secondary	Progression Free Survival Based on Treatment Analysis- ITT Population	Progression free survival was defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria and was based on treatment analysis. PFS analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.	Up to 3 years	No
Secondary	Progression Free Survival Based on Treatment Analysis-PP Population	Progression free survival was defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria and was based on treatment analysis. PFS analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.	Up to 3 years	No
Secondary	Best Overall Response (BOR), Investigators' Assessments	The best overall response in a participant was defined according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as the best response recorded from the start of treatment until disease progression or recurrence (the reference for disease progression was the smallest measurement recorded since the baseline assessment). To be assigned a status of partial response (PR) or complete response (CR), changes in tumor measurements were confirmed by repeat assessments performed no fewer than 4 weeks after the criteria for response were first met. Only tumor assessments by the investigator up to and including 28 days after the last intake of study medication in the primary study treatment phase were considered for determining the best overall response of a participant. The analysis of best overall response was also performed using tumor assessments made by the Investigator	Up to 3 years	No
Secondary	Best Overall Response (BOR), Independent Review Committee (IRC) Assessment	The best overall response in a participant was defined according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as the best response recorded from the start of treatment until disease progression or recurrence (the reference for disease progression was the smallest measurement recorded since the baseline assessment). To be assigned a status of partial response (PR) or complete response (CR), changes in tumor measurements were confirmed by repeat assessments performed no fewer than 4 weeks after the criteria for response were first met. Only tumor assessments by the investigator up to and including 28 days after the last intake of study medication in the primary study treatment phase were considered for determining the best overall response of a participant. The analysis of best overall response was performed using tumor assessments made by the IRC.	Up to 3 years	No
Secondary	Overall Survival	Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.	Up to 3 years	No
Secondary	Time To Response (TOR)	Time to response (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met.	Up to 3 years	No
Secondary	Duration Of Response (DOR)	Duration of response was defined as the time that measurement criteria were first met for CR or PR (whichever was recorded first) until the first date that progressive disease (PD) or death was documented. The data from participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants who neither progressed nor died were censored at the date of the last tumor assessment. For complete responders, the duration of CR was measured from the time measurement criteria for CR were first met until the date that PD (or death) was documented.	Up to 3 years	No
Secondary	Time To Treatment Failure	Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.	Up to 3 years	No
Secondary	Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment	Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.	Up to 3 years	No