Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin, etoposide, and paclitaxel are more effective than cisplatin and etoposide alone in treating patients with extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus etoposide with or without paclitaxel in treating patients with extensive-stage small cell lung cancer.

Timeline

Start

1998-04

Primary completion

2005-06

Completion

2006-01

Outcome

Missed primary endpoint

paper PET did not improve the time to progression or survival in patients with extensive SCLC compared with EP alone PMID 15923572 ↗

Publications

• Background Blackstock AW, Herndon JE 2nd, Paskett ED, Miller AA, Lathan C, Niell HB, Socinski MA, Vokes EE, Green MR; Cancer and Leukemia Group B. Similar outcomes between African American and non-African American patients with extensive-stage small-cell lung carcinoma: report from the Cancer and Leukemia Group B. J Clin Oncol. 2006 Jan 20;24(3):407-12. doi: 10.1200/JCO.2005.02.1436. Epub 2005 Dec 19.
• Results Niell HB, Herndon JE 2nd, Miller AA, Watson DM, Sandler AB, Kelly K, Marks RS, Perry MC, Ansari RH, Otterson G, Ellerton J, Vokes EE, Green MR; Cancer and Leukemia Group. Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer: Cancer and Leukemia Group B Trial 9732. J Clin Oncol. 2005 Jun 1;23(16):3752-9. doi: 10.1200/JCO.2005.09.071.
• Results Niell HB, Herndon JE, Miller AA, et al.: Randomized phase III intergroup trial (CALGB 9732) of etoposide (VP-16) and cisplatin (DDP) with or without paclitaxel (TAX) and G-CSF in patients with extensive stage small cell lung cancer (ED-SCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1169, 2002.
• Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.

Drugs

Indications