drugset / Trial / NCT00025142
Gefitinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Colorectal Cancer
Treatment
Summary
RATIONALE: Biological therapies such as gefitinib 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 more than one drug with gefitinib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gefitinib and oxaliplatin combined with leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal cancer.
Timeline
- Start
- 2001-07
- Primary completion
- —
- Completion
- 2006-11
Publications
- Results Fisher GA, Kuo T, Ramsey M, Schwartz E, Rouse RV, Cho CD, Halsey J, Sikic BI. A phase II study of gefitinib, 5-fluorouracil, leucovorin, and oxaliplatin in previously untreated patients with metastatic colorectal cancer. Clin Cancer Res. 2008 Nov 1;14(21):7074-9. doi: 10.1158/1078-0432.CCR-08-1014.
- Results Kuo T, Cho CD, Halsey J, Wakelee HA, Advani RH, Ford JM, Fisher GA, Sikic BI. Phase II study of gefitinib, fluorouracil, leucovorin, and oxaliplatin therapy in previously treated patients with metastatic colorectal cancer. J Clin Oncol. 2005 Aug 20;23(24):5613-9. doi: 10.1200/JCO.2005.08.359.
- Results Cho CD, Fisher GA, Halsey JZ, et al.: A phase I study of ZD1839 (Iressa) in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) in advanced solid malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-38, 2002.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gefitinib | Small molecule | 500 mg | Oral |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 600 mg/m2 | Intravenous |