Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: 5-fluorouracil; Drug: AZD2171; Drug: Leucovorin; Drug: Bevacizumab; Drug: Oxaliplatin

• Registration Number: NCT00278889
• Lead Sponsor: AstraZeneca

Brief Summary

The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-19
• Primary Completion: 2007-11
• Study Completion: 2009-10
• Disposition First Submitted: 2011-04-06
• Disposition First Submitted QC: 2011-04-06
• Disposition First Posted: 2011-04-12
• Results First Submitted: 2012-07-26
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-24
• Last Update Submitted: 2012-09-24
• Results First Posted: 2012-10-24
• Last Update Posted: 2012-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• Clinical diagnosis of colon or rectal cancer,
• Received prior systemic therapy for cancer,
• Cancer must have progressed during or after first treatment

Exclusion Criteria

• Prior treatment with a VEGF inhibitor,
• Poorly controlled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bevacizumab	Bevacizumab + FOLFOX
1	5-fluorouracil	Bevacizumab + FOLFOX
1	Leucovorin	Bevacizumab + FOLFOX
2	Oxaliplatin	AZD2171 + FOLFOX
2	AZD2171	AZD2171 + FOLFOX
1	Oxaliplatin	Bevacizumab + FOLFOX
2	5-fluorouracil	AZD2171 + FOLFOX
2	Leucovorin	AZD2171 + FOLFOX

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Randomisation to data cut-off date of November 2007	Number of months from randomisation to the earlier date of objective progression or death

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	Randomisation to data cut-off date of November 2007	Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.; Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.
Overall Survival	Randomisation to data cut-off date of 30 January 2009	Number of months from randomisation to the date of death from any cause
Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)	Randomisation to data cut-off date of November 2007	Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
QOL: Time to Worsening of Treatment-free Survival (TFS)	Randomisation to data cut-off date of November 2007	Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
QOL: Time to Worsening of Clear Cell Sarcoma (CCS)	Randomisation to data cut-off date of November 2007	Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)	Randomisation to data cut-off date of November 2007	Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

Trial Locations

Locations (2)

Research Site; 🇬🇧 Sutton, United Kingdom

Ressearch Site; 🇧🇪 Brussels, Belgium