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

AstraZeneca

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Colorectal Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494221

D8480C00039

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 3 patient groups, including a placebo group

FOLFOX + Cediranib 20 mg

Active Comparator group

Description:

FOLFOX + Cediranib 20 mg

Treatment:

Drug: AZD2171

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

FOLFOX + Cediranib 30 mg

Active Comparator group

Description:

FOLFOX + Cediranib 30 mg

Treatment:

Drug: AZD2171

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

FOLFOX + Placebo Cediranib

Placebo Comparator group

Description:

FOLFOX + Placebo Cediranib

Treatment:

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

Drug: Placebo Cediranib