Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Metastases, Neoplasm; Colorectal Neoplasms

Treatments: Drug: Placebo; Drug: leucovorin; Drug: 5-fluorouracil; Drug: ZD6126; Drug: oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00065117

6126IL/00007

D2820C00007

Details and patient eligibility

About

The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic Colorectal Cancer.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic colorectal carcinoma
• Suitable for first-line treatment of metastatic disease

Exclusion criteria

• Peripheral neuropathy greater than Grade 1
• Adjuvant therapy within 6 months prior to study treatment
• Prior oxaliplatin
• Prior pelvic or whole abdomen radiation
• Any history of coronary angioplasty or history of myocardial infarction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind