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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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic, Colorectal, Adenocarcinoma

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

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

Outcome Time Frame:

assessed at each visit

Safety Issue:

No

Principal Investigator

Mark Saunders, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: National Health Service

Study ID:

D4200C00038

NCT ID:

NCT00507091

Start Date:

August 2005

Completion Date:

June 2008

Related Keywords:

  • Metastatic
  • Colorectal
  • Adenocarcinoma
  • ZD6474
  • Irinotecan
  • 5-Fluorouracil
  • Leucovorin
  • colorectal
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

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