Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer
Summary
This randomized phase I/II trial studies the side effects and best dose of veliparib when given together with or without cisplatin and etoposide and to see how well they work in treating patients with extensive stage small cell lung cancer or large cell neuroendocrine non-small cell lung cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work better in treating patients with extensive stage small cell lung cancer or metastatic large cell neuroendocrine non-small cell lung cancer.
Timeline
- Start
- 2012-09-28
- Primary completion
- 2016-12-08
- Completion
- 2018-07-02
Publications
- Results Owonikoko TK, Dahlberg SE, Sica GL, Wagner LI, Wade JL 3rd, Srkalovic G, Lash BW, Leach JW, Leal TB, Aggarwal C, Ramalingam SS. Randomized Phase II Trial of Cisplatin and Etoposide in Combination With Veliparib or Placebo for Extensive-Stage Small-Cell Lung Cancer: ECOG-ACRIN 2511 Study. J Clin Oncol. 2019 Jan 20;37(3):222-229. doi: 10.1200/JCO.18.00264. Epub 2018 Dec 5.
- Steffen McLouth LE, Zhao F, Owonikoko TK, Feliciano JL, Mohindra NA, Dahlberg SE, Wade JL 3rd, Srkalovic G, Lash BW, Leach JW, Leal TA, Aggarwal C, Cella D, Ramalingam SS, Wagner LI. Patient-reported tolerability of veliparib combined with cisplatin and etoposide for treatment of extensive stage small cell lung cancer: Neurotoxicity and adherence data from the ECOG ACRIN cancer research group E2511 phase II randomized trial. Cancer Med. 2020 Oct;9(20):7511-7523. doi: 10.1002/cam4.3416. Epub 2020 Aug 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Veliparib | Small molecule | 100 mg | Oral |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |