Phase I FOLFOX Combination

Genzyme

Status and phase: Completed; Phase 1

Conditions: Advanced Colorectal Carcinoma

Treatments: Drug: ZD6474 (vandetanib); Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00499850

D4200C00037

Details and patient eligibility

About

A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)
2. WHO performance status 0-1
3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques

Exclusion criteria

1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
3. prior unanticipated severe reaction to oxaliplatin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)