drugset / Trial / NCT00026364

ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer

NCT00026364

Phase 1 Completed 22 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan, leucovorin, and fluorouracil in treating patients who have locally advanced, locally recurrent, or metastatic colorectal cancer. Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ZD 1839 with combination chemotherapy may kill more tumor cells.

Timeline

Start
2001-11
Primary completion
2006-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 250 mg Oral
Subject Gefitinib Small molecule 500 mg Oral
Subject Irinotecan Small molecule 100 mg/m2 Intravenous
Subject Irinotecan Small molecule 125 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 20 mg/m2 Intravenous
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 500 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications