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Completed

NCT Number: NCT00345761

Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

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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

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hokkaido Region, Hokkaido, Japan

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About this study

This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients 20-74 years of age
  • Histologically confirmed colorectal cancer
  • Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease
  • At least one measurable lesion according to RECIST

Exclusion criteria

  • Evidence of clinically detectable ascites at study treatment start
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.
  • Evidence of bleeding diathesis or coagulopathy
  • Serious, non-healing wound, ulcer, or bone fracture
  • Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration

Treatment and study plan

Bevacizumab

Drug

7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)

Oxaliplatin

Drug

130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)

Capecitabine

Drug

2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Primary outcomes

  1. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: event driven

  2. Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)

    Time frame: throughout study

Secondary outcomes

  1. time to progression

    Time frame: event driven

  2. overall survival

    Time frame: event driven

  3. time to response

    Time frame: event driven

  4. duration of response

    Time frame: event driven

  5. concentrations of R340 and its metabolites

    Time frame: throughout study

  6. concentrations of platinum

    Time frame: throughout study

  7. concentrations of bevacizumab

    Time frame: throughout study

  8. concentrations of vascular endothelial growth factor (VEGF)

    Time frame: throughout study

  9. concentrations of anti-bevacizumab antibody

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Collaborators

  • Yakult Honsha Co., LTD

Registry information

Official study title

Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Jun 28, 2006
Registry last updated
Aug 16, 2010

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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