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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233623

Enrollment

190

Registered

2005-10-06

Start date

2004-07-31

Completion date

2006-01-31

Last updated

2011-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer

Brief summary

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.

Interventions

DRUGIressa (Gefitinib)

DRUGIrinotecan

DRUG5Fluorouracil

DRUGLeucovorin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Time to progression (6 months after Last patient in)	—

Secondary

Measure	Time frame
Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026