A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
![]() |
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: NCT00118755 |
Recruitment Status
:
Completed
First Posted
: July 12, 2005
Results First Posted
: March 3, 2011
Last Update Posted
: March 3, 2011
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: capecitabine Drug: Oxaliplatin Drug: bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 435 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: capecitabine
850 mg/m^2 po bid on Days 1-14 of each 3-week cycle
Drug: Oxaliplatin
130 mg/m^2 IV on Day 1 of each 3-week cycle
Drug: bevacizumab
7.5 mg/kg IV on Day 1 of each 3-week cycle
|
Active Comparator: 2 |
Drug: capecitabine
1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle
Drug: Oxaliplatin
85 mg/m^2 IV on Day 1 of each 2-week cycle
Drug: bevacizumab
5 mg/kg IV on Day 1 of each 2-week cycle
|
- Progression-free Survival (PFS) [ Time Frame: Time to disease progression or death (through follow-up phase) ]Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).
- Overall Survival [ Time Frame: Time to death (through follow-up phase): Approximate Median of 718 days ]Overall survival was defined as the time from the date of randomization to the date of death, for any cause.
- Best Overall Clinical Response [ Time Frame: Through follow-up phase: Approximate Median of 318 days ]Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
- Duration of Overall Clinical Response (CR or PR) [ Time Frame: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days ]Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Metastatic or inoperable locally advanced colorectal cancer
- >=1 measurable target lesion
Exclusion Criteria:
- Previous systemic therapy for advanced or metastatic disease
- Previous treatment with bevacizumab

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118755
Study Director: | Clinical Trials | Hoffmann-La Roche |
Additional Information:
Responsible Party: | Disclosures Group, Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00118755 History of Changes |
Other Study ID Numbers: |
ML18491 |
First Posted: | July 12, 2005 Key Record Dates |
Results First Posted: | March 3, 2011 |
Last Update Posted: | March 3, 2011 |
Last Verified: | February 2011 |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Bevacizumab |
Oxaliplatin Capecitabine Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |