Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iressa (Gefitinib) | Drug | |||
| Irinotecan | Drug | |||
| 5Fluorouracil | Drug | |||
| Leucovorin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression (6 months after Last patient in) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Italy Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Bari | Italy | ||||
| Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bergamo |
| Italy |
| Research Site | Catania | Italy |
| Research Site | Cremona | Italy |
| Research Site | Cuneo | Italy |
| Research Site | La Spezia | Italy |
| Research Site | L’Aquila | Italy |
| Research Site | Milan | Italy |
| Research Site | Palermo | Italy |
| Research Site | Pescara | Italy |
| Research Site | Rozzano | Italy |
| Research Site | Torino | Italy |
| Research Site | Venezia | Italy |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided