A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer - Full Text View

Purpose

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. 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)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine [Xeloda] Drug: Oxaliplatin Drug: Leucovorin Drug: 5 FU	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-label Study of the Effect of Intermittent Xeloda in Combination With Eloxatin, Versus Fluorouracil/Leucovorin, on Disease-free Survival in Patients Who Have Undergone Surgery for Colon Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin calcium Oxaliplatin Levoleucovorin Capecitabine

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Disease-free Survival (DFS) [Number of Events] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos. ] [ Designated as safety issue: No ]
Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.
Disease-free Survival [Time to Event] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos. ] [ Designated as safety issue: No ]
Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.

Secondary Outcome Measures:

Relapse-free Survival (RFS) [Number of Events] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos. ] [ Designated as safety issue: No ]
Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer.
Relapse-free Survival (RFS) [Time to Event] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos. ] [ Designated as safety issue: No ]
Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.
Overall Survival [Number of Events] [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ] [ Designated as safety issue: No ]
Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Overall Survival [Time to Event] [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ] [ Designated as safety issue: No ]
Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Number of Participants Assesed for Adverse Events [ Time Frame: followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake ] [ Designated as safety issue: No ]
Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline.

See Adverse Events module for details.

Enrollment:	1886
Study Start Date:	January 2003
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: capecitabine [Xeloda] 1000mg/m2 iv bid on days 1-15 of each 3 week cycle Drug: Oxaliplatin As prescribed, in 3 week cycles
Active Comparator: 2	Drug: Oxaliplatin As prescribed, in 2 week cycles Drug: Leucovorin As prescribed, in 2 week cycles. Drug: 5 FU As prescribed, in 2 week cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients >=18 years of age;
colon cancer;
complete tumor resection.

Exclusion Criteria:

prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069121

Show 256 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00069121 History of Changes
Obsolete Identifiers:	NCT00080691
Other Study ID Numbers:	NO16968
Study First Received:	September 15, 2003
Results First Received:	March 31, 2011
Last Updated:	April 15, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Levoleucovorin
Oxaliplatin

Capecitabine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013