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OpenTrials
Completed

NCT Number: NCT00642577

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.

This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 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 3

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients, >=18 years of age;
  • histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
  • >=1 measurable lesion;
  • ECOG performance status of <=1.

Exclusion criteria

  • prior systemic therapy for advanced or metastatic disease;
  • adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
  • other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
  • clinically significant cardiovascular disease in past 6 months.

Treatment and study plan

bevacizumab [Avastin]

Drug

5mg/kg iv every 2 weeks

Irinotecan

Drug

125mg/m2 iv weekly for 4 weeks of each 6 week cycle

Leucovorin

Drug

20mg/m2 iv weekly for 4 weeks of each 6 week cycle

Fluorouracil

Drug

500mg/m2 iv weekly for 4 weeks of each 6 week cycle

Primary outcomes

  1. Progression-free survival.

    Time frame: 6 months

Secondary outcomes

  1. Overall response rate, time to response, duration of response, overall survival.

    Time frame: Event driven

  2. AEs, laboratory tests

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open Label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Irinotecan + 5-fluorouracil/Folinic Acid, and Irinotecan + 5-fluorouracil/Folinic Acid Alone, on Progression-free Survival in Chinese Patients With Metastatic Colorectal Cancer.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 25, 2008
Registry last updated
Dec 22, 2022

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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