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Completed

NCT Number: NCT00056446

Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer

The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Frankston, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease
  • One prior chemotherapy regimen with irinotecan and 5FU
  • Evidence of progressive disease within 6 months after last dose of irinotecan
  • WHO Performance Status of 0, 1, or 2
  • Measurable tumors
  • Adequate hematologic status, liver and kidney function
  • Life expectancy greater than 12 weeks
  • Written informed consent obtained

Exclusion criteria

  • History or presence of central nervous system disease
  • Patients with a history of another primary cancer within 5 years
  • Prior chemotherapy within 3 weeks before entry to study
  • Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
  • Investigational drugs within 4 weeks before entry to study
  • Prior therapy with oxaliplatin
  • Peripheral neuropathy with functional impairment
  • Female patients who are pregnant or breast feeding
  • Any severe or uncontrolled medical condition which could prevent participation in study
  • Chronic kidney disease
  • Acute or chronic liver disease
  • Patients taking Coumadin

Treatment and study plan

vatalanib

Drug

Other names: PTK787/ZK 222584

Primary outcomes

  1. Overall survival

    Time frame: throughout duration of study

Secondary outcomes

  1. Progression free survival

    Time frame: throughout duration of study

  2. Time to progression

    Time frame: throughout duration of study

  3. Time to treatment failure

    Time frame: throughout duration of study

  4. Tumor response rate

    Time frame: throughout duration of study

  5. Tolerability and safety profile

    Time frame: throughout duration of study

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Bayer

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Mar 14, 2003
Registry last updated
Mar 6, 2017

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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