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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

Phase 3
18 Years
Not Enrolling
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

Thank you

Trial Information

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

Inclusion Criteria

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

- Chronic kidney disease

- Acute or chronic liver disease

- Patients taking Coumadin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

throughout duration of study

Safety Issue:


Principal Investigator

Novartis/Schering AG, Germany

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis / Schering AG Germany


United States: Food and Drug Administration

Study ID:

CPTK787 0133/304946



Start Date:

January 2003

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Cancer
  • Oxaliplatin
  • VEGF inhibitor
  • Vatalanib
  • PTK787
  • Colon Cancer
  • Colorectal Carcinoma
  • Rectal Cancer
  • Colorectal Tumor
  • Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Rectal Neoplasms



University of MichiganAnn Arbor, Michigan  48109-0624
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Atlanta Cancer CareAtlanta, Georgia  30342
St. Agnes HealthcareBaltimore, Maryland  21229
Owensboro Medical Health SystemOwensboro, Kentucky  42303
Saint Louis UniversitySt. Louis, Missouri  63104
Meharry Medical CollegeNashville, Tennessee  37208-3599
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Arch Medical Services IncorporatedSt. Louis, Missouri  63141
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