Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Collaborator:
Bayer
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00056446
First received: March 13, 2003
Last updated: November 18, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms |
Drug: Vatalanib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Overall survival [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
- Tumor response rate [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
- Tolerability and safety profile [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
| Enrollment: | 855 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Oxaliplatin/5-FU/LV and PTK787/ZK 222584
|
Drug: Vatalanib
Other Name: PTK787/ZK 222584
|
|
Placebo Comparator: 2
Oxaliplatin/5-FU/LV and placebo
|
Drug: Vatalanib
Other Name: PTK787/ZK 222584
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 study
- Chronic kidney disease
- Acute or chronic liver disease
- Patients taking Coumadin
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056446
Show 251 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056446
Show 251 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Bayer
Investigators
| Study Chair: | Novartis/Schering AG, Germany | Novartis / Schering AG Germany |
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00056446 History of Changes |
| Obsolete Identifiers: | NCT00068679 |
| Other Study ID Numbers: | CPTK787 0133/304946 |
| Study First Received: | March 13, 2003 |
| Last Updated: | November 18, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Colorectal Cancer Oxaliplatin VEGF inhibitor Vatalanib PTK787 |
Colon Cancer Colorectal Carcinoma Rectal Cancer Colorectal Tumor |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms by Site |
Rectal Diseases Oxaliplatin Vatalanib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015