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Completed

NCT Number: NCT00118755

A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

850 mg/m^2 po bid on Days 1-14 of each 3-week cycle

Oxaliplatin

Drug

130 mg/m^2 IV on Day 1 of each 3-week cycle

Bevacizumab

Drug

7.5 mg/kg IV on Day 1 of each 3-week cycle

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2009
First posted
Jul 12, 2005
Registry last updated
Mar 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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