A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer

Genzyme

Status and phase: Completed; Phase 2

Conditions: Colorectal; Cancer

Treatments: Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid; Drug: Vandetanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00500292

D4200C00047

2006-005022-23 (EudraCT Number)

LPS15025 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Progression on or following treatment for metastatic colorectal cancer
• Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
• Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks

Exclusion criteria

• Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
• Previous adjuvant therapy with irinotecan within 12 months of randomisation
• More than one prior course of chemotherapy for treatment of metastatic colorectal cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

FOLFOX + Placebo vandetanib

Treatment:

Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid

2

Experimental group

Description:

FOLFOX + low dose vandetanib

Treatment:

Drug: Vandetanib

Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid

3

Experimental group

Description:

FOLFOX + high dose vandetanib

Treatment:

Drug: Vandetanib

Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid