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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00507091
First received: July 10, 2007
Last updated: April 3, 2009
Last verified: April 2009

July 10, 2007
April 3, 2009
August 2005
May 2006   (final data collection date for 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 ] [ Designated as safety issue: No ]
Establish the safety & efficacy of ZD6474 w/5-fluorouracil,lecovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, haematology, urinalysis, ECG and physical examinations
Complete list of historical versions of study NCT00507091 on ClinicalTrials.gov Archive Site
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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic
  • Colorectal
  • Adenocarcinoma
  • Drug: ZD6474 (vandetanib)
    once daily oral tablet
    Other Name: ZACTIMA™
  • Drug: Irinotecan
    intravenous infusion
    Other Name: Camptosar®
  • Drug: 5-Fluorouracil
    intravenous infusion
    Other Name: 5-FU
  • Drug: Leucovorin
    intravenous infusion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2008
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Confirmed metastatic colorectal adenocarcinoma
  2. Not amenable to surgery or radiation therapy
  3. For first or second line chemotherapy

Exclusion Criteria:

  1. Brain metastases or spinal compression
  2. Last prior chemotherapy discontinued within 4 weeks before start
  3. Last dose radiotherapy within 4 weeks of start
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United Kingdom
 
NCT00507091
D4200C00038
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AstraZeneca
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Principal Investigator: Mark Saunders, MD AstraZeneca
Study Director: Peter Langmuir AstraZeneca
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP