Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer

AstraZeneca

Status and phase

Withdrawn

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: 5Fluorouracil

Drug: Iressa (Gefitinib)

Drug: Irinotecan

Drug: Leucovorin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233623

1839IL/0138

Details and patient eligibility

About

The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)