Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer
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| ClinicalTrials.gov Identifier: NCT00056446 |
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Recruitment Status :
Completed
First Posted : March 14, 2003
Last Update Posted : March 6, 2017
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Sponsor:
Novartis Pharmaceuticals
Collaborator:
Bayer
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms | Drug: Vatalanib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 855 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | January 2003 |
| Actual Primary Completion Date : | January 2007 |
| Actual Study Completion Date : | January 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Colorectal Cancer
Drug Information available for:
Oxaliplatin
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Oxaliplatin/5-FU/LV and PTK787/ZK 222584
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Drug: Vatalanib
Other Name: PTK787/ZK 222584 |
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Placebo Comparator: 2
Oxaliplatin/5-FU/LV and placebo
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Drug: Vatalanib
Other Name: PTK787/ZK 222584 |
Primary Outcome Measures :
- Overall survival [ Time Frame: throughout duration of study ]
Secondary Outcome Measures :
- Progression free survival [ Time Frame: throughout duration of study ]
- Time to progression [ Time Frame: throughout duration of study ]
- Time to treatment failure [ Time Frame: throughout duration of study ]
- Tumor response rate [ Time Frame: throughout duration of study ]
- Tolerability and safety profile [ Time Frame: throughout duration of study ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056446
Show 251 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Bayer
Investigators
| Study Chair: | Novartis/Schering AG, Germany | Novartis / Schering AG Germany |
Additional Information:
Publications of Results:
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00056446 History of Changes |
| Obsolete Identifiers: | NCT00068679 |
| Other Study ID Numbers: |
CPTK787 0133/304946 |
| First Posted: | March 14, 2003 Key Record Dates |
| Last Update Posted: | March 6, 2017 |
| Last Verified: | January 2016 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Colorectal Cancer Oxaliplatin VEGF inhibitor Vatalanib PTK787 |
Colon Cancer Colorectal Carcinoma Rectal Cancer Colorectal Tumor |
Additional relevant MeSH terms:
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Neoplasms Colorectal Neoplasms Rectal Neoplasms Colonic Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin Vatalanib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |