Know Cancer

or
forgot password

A Randomised, Non-Comparative, Multicentre, Phase II, Parallel-Group Trial Of ZD1839 (Iressa™) In Combination With 5 Fluorouracil, Leucovorin And Cpt-11 (Irinotecan) In Patients With Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

A Randomised, Non-Comparative, Multicentre, Phase II, Parallel-Group Trial Of ZD1839 (Iressa™) In Combination With 5 Fluorouracil, Leucovorin And Cpt-11 (Irinotecan) In Patients With Metastatic Colorectal Cancer


Inclusion Criteria:



- Histologically confirmed metastatic colorectal cancer

- Presence of measurable metastases

- No previous treatment for metastatic cancer

Exclusion Criteria:

- No presence of Central Nervous System metastases

- No other co-existing malignancies or malignancies diagnosed within the last 5 years
with the exception of basal cell carcinoma or cervical cancer in situ

- Any evidence of severe or uncontrolled systemic disease (e.g. unstable or
uncompensated respiratory, cardiac, hepatic or renal disease)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression (6 months after Last patient in)

Principal Investigator

AstraZeneca Italy Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Italy: Ministry of Health

Study ID:

1839IL/0138

NCT ID:

NCT00233623

Start Date:

July 2004

Completion Date:

January 2006

Related Keywords:

  • Metastatic Colorectal Cancer
  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

Name

Location