drugset / Trial / NCT00004055
Topotecan, Paclitaxel, and Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Phase 2
Completed
38 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of topotecan, paclitaxel, and filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
Timeline
- Start
- 1999-11
- Primary completion
- 2004-07
- Completion
- 2004-07
Publications
- Background Foster NR, Qi Y, Shi Q, Krook JE, Kugler JW, Jett JR, Molina JR, Schild SE, Adjei AA, Mandrekar SJ. Tumor response and progression-free survival as potential surrogate endpoints for overall survival in extensive stage small-cell lung cancer: findings on the basis of North Central Cancer Treatment Group trials. Cancer. 2011 Mar 15;117(6):1262-71. doi: 10.1002/cncr.25526. Epub 2010 Oct 19.
- Results Molina JR, Jett JR, Foster N, Lair BS, Carroll TJ, Tazelaar HD, Hillman S, Mailliard JA, Bernath AM Jr, Nikcevich D. Phase II NCCTG trial of oral topotecan and paclitaxel with G-CSF (filgrastim) support in patients with previously untreated extensive-stage small cell lung cancer. Am J Clin Oncol. 2006 Jun;29(3):246-51. doi: 10.1097/01.coc.0000217566.11742.b5.
- Results Jett JR, Bernath AM Jr, Hillman SL, et al.: Oral topotecan and paclitaxel with G-CSF support in patients with untreated extensive stage small cell (ED-SCLC): a phase II trial of the NCCTG. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1301, 2002.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 1.75 mg/m2 | Oral |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |