Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Sponsor
Genzyme, a Sanofi Company
Study ID
NCT00507091
Phase
PHASE1
Status
Completed

Conditions

  • Adenocarcinoma
  • Colorectal
  • Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZD6474 (vandetanib) 100mg — DRUG
    once daily oral tablet
  • Irinotecan — DRUG
    intravenous infusion
  • 5-Fluorouracil — DRUG
    intravenous infusion
  • Leucovorin — DRUG
    intravenous infusion
  • ZD6474 (vandetanib) 300mg — DRUG
    once daily oral tablet

Study Details

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Key Dates

Start date
Aug 31, 2005
Status verified
Aug 2016
Primary completion
May 31, 2006
Completion
Jun 30, 2008

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ZD6474 (vandetanib) 100mg
  • Experimental: ZD6474 (vandetanib) 300mg

Primary Outcome Measure

Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations [ Time Frame: assessed at each visit ]

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