A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

Genzyme

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Vandetanib; Drug: FOLFIRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454116

2006-005023-42 (EudraCT Number)

D4200C00048

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed colorectal cancer
• Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
• Progression on or following treatment for metastatic colorectal cancer
• Progression within 12 months of adjuvant chemotherapy for colorectal cancer

Exclusion criteria

• Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
• Previous adjuvant therapy with irinotecan within 12 months of randomization
• 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

---

106 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

FOLFIRI + placebo vandetanib

Treatment:

Drug: FOLFIRI

2

Experimental group

Description:

FOLFIRI + low dose vandetanib

Treatment:

Drug: FOLFIRI

Drug: Vandetanib

3

Experimental group

Description:

FOLFIRI + high dose vandetanib

Treatment:

Drug: FOLFIRI

Drug: Vandetanib