A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX

NCT00494221 | Completed Phase 1 Results

• 1 other identifier: D8480C00039
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it's better than giving standard treatment alone in helping to prevent progression of mCRC.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal cancer; Recentin; Metastatic Cancer; FOLFOX

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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.

  RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)

Secondary Outcomes (4)

• Objective Tumour Response Rate

  RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)

• Best Percentage Change in Tumour Size

  Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)

• Duration of Response

  RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)

• Overall Survival

  Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)

Study Arms (3)

FOLFOX + Cediranib 20 mg

ACTIVE COMPARATOR

FOLFOX + Cediranib 20 mg

Drug: AZD2171; Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

FOLFOX + Cediranib 30 mg

ACTIVE COMPARATOR

FOLFOX + Cediranib 30 mg

Drug: AZD2171; Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

FOLFOX + Placebo Cediranib

PLACEBO COMPARATOR

FOLFOX + Placebo Cediranib

Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); Drug: Placebo Cediranib

Interventions

AZD2171 DRUG

oral tablet

Also known as: cediranib, RECENTIN™

FOLFOX + Cediranib 20 mg; FOLFOX + Cediranib 30 mg

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) DRUG

intravenous infusion

Also known as: Eloxatin®, 5-FU, Leucovorin

FOLFOX + Cediranib 20 mg; FOLFOX + Cediranib 30 mg; FOLFOX + Placebo Cediranib

Placebo Cediranib DRUG

oral tablet

FOLFOX + Placebo Cediranib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic colorectal cancer
• WHO performance status 0-1
• Life expectancy is 12 weeks or longer

You may not qualify if:

• Patient with uncontrolled brain metastases
• Patient with inappropriate laboratory tests values
• Patient with poorly controlled hypertension

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Osaka, Japan

Location

Research Site

Saitama, Japan

Location

Related Links

• CSR-D8480C00039.pdf

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

cediranib; Folfox protocol; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Jane Robertson

  AstraZeneca

  STUDY DIRECTOR

• Hideyuki Mishima, M.D., PhD

  National Hospital Organization Osaka National Hospital

  PRINCIPAL INVESTIGATOR

• Xiaojin Shi, MD

  AstraZeneca

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: June 27, 2007
• First Posted: June 29, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: August 1, 2012
• Last Updated: March 27, 2014
• Results First Posted: June 5, 2012

Record last verified: 2014-02

Locations

JP (2)