Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versu... | NCT00056459

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

NCT00056459

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 10, 2020Actual

Enrollment

1,168Actual

Phase

Phase 3

Conditions

Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms

Interventions

Vatalanib

Countries

United States
Australia
Belgium
Brazil
Canada
Czechia
France
Germany
Hungary
Italy
Netherlands
New Zealand
Portugal
Slovakia
Spain
Sweden
Switzerland
Taiwan
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
CONFIRM 1

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Jan 2007Actual

Completion Date

Not provided

First Submitted Date

Mar 13, 2003

First Submission Date that Met QC Criteria

Mar 13, 2003

First Posted Date

Mar 14, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2020

Last Update Posted Date

Feb 10, 2020Actual

Name	Class
Bayer	INDUSTRY

Description Module

Brief Summary

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 are seeking first chemotherapy treatment

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Oxaliplatin/5-FU/LV and PTK787/ZK 222584	Drug: Vatalanib
2	Placebo Comparator	Oxaliplatin/5-FU/LV and placebo	Drug: Vatalanib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vatalanib	Drug		1 2	PTK787/ZK 222584

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival		Throughout duration of study

Secondary Outcomes

Measure	Description	Time Frame
Time to progression		Throughout duration of study
Time to treatment failure		Throughout duration of study
Best overall response rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients with metastatic colorectal cancer coming for initial chemotherapy
Documented metastatic colorectal cancer
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 for metastatic colorectal cancer
Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 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 anti-VEGF agents
Any prior therapy with oxaliplatin or allergy to platinum-containing drugs
Peripheral neuropathy with functional impairment
Female patients who are pregnant or breast feeding
Any severe or uncontrolled medical conditions which could prevent participation in study
Patients who are taking Coumadin

Other protocol-defined inclusion / exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis / Schering AG, Germany	Novartis / Schering AG, Germany	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Hematology/Oncology		Birmingham	Alabama	35243	United States
Palo Verde Hematology & Oncology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21464406	Derived	Hecht JR, Trarbach T, Hainsworth JD, Major P, Jager E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms