Trials Sponsors Conditions Drugs Pricing

Conditions

Colorectal Cancer

Keywords

Metastatic Colorectal CancerRECENTIN

Outcome Measures

Primary Outcomes (1)

Progression Free Survival
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression

Secondary Outcomes (5)

Overall Survival
Randomisation until data cut-off
Objective Response Rate
Up until data cut-off
Duration of Response
Up until data cut-off date of 15/11/2007
Percentage Change in Tumour Size
Baseline to Week 8
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
Baseline through to data cut-off

Study Arms (2)

1

ACTIVE COMPARATOR

Bevacizumab + FOLFOX

Drug: BevacizumabDrug: 5-fluorouracil ( in FOLFOX)Drug: Leucovorin (in FOLFOX)Drug: Oxaliplatin (in FOLFOX)

2

EXPERIMENTAL

Cediranib + FOLFOX

Drug: CediranibDrug: 5-fluorouracil ( in FOLFOX)Drug: Leucovorin (in FOLFOX)Drug: Oxaliplatin (in FOLFOX)

Interventions

CediranibDrug

oral tablet once daily

Also known as: RECENTIN™, AZD2171

BevacizumabDrug

intravenous infusion

Also known as: Avastin®

Eligibility Criteria

Age18 Years - 130 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Clinical Diagnosis of colon or rectal cancer
No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received \>12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received \>6 months prior to study entry.

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (280)

Research Site

Anniston, Alabama, United States

Research Site

Birmingham, Alabama, United States

Research Site

Casa Grande, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Hot Springs, Arkansas, United States

Research Site

Palm Springs, California, United States

Research Site

San Diego, California, United States

Related Publications (3)

Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
PMID: 31378656DERIVED
Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
PMID: 30679026DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

cediranibBevacizumabFluorouracilFolfox protocolLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Results Point of Contact

Title: Gerard Lynch
Organization: AstraZeneca

Study Officials

Jane Robertson
AstraZeneca
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

1,814 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 3, 2006

First Posted

October 5, 2006

Study Start

August 30, 2006

Actual (reported)

First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (280)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (280)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations