Phase I FOLFOX Combination

Advanced Colorectal Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499850
• Other study ID #: D4200C00037
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2007
• Last updated: August 24, 2016
• Start date: August 2005
• Est. completion date: April 2008

Study information

• Verified date: August 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Drug:
• ZD6474 (vandetanib)
once daily oral dose
• 5-Fluorouracil
intravenous infusion
• Leucovorin
intravenous infusion
• Oxaliplatin
intravenous infusion

Locations

Country	Name	City	State
Australia	Research Site	East Melbourne
Australia	Research Site	Footscray
Australia	Research Site	Heidelberg
Australia	Research Site	Parkville

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin		Assessed at each visit	No