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

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.

Sex

All

Minimum age

18 Years

DISEASE CHARACTERISTICS: Histologically or cytologically documented extensive stage small cell carcinoma of the bronchus Measurable or evaluable disease No pleural effusions, bone scan abnormalities, or bone marrow biopsies as only evidence of disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-1 Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times normal Renal: Serum creatinine no greater than 1.5 mg/dL Cardiovascular: No cardiac disease Pulmonary: No interstitial pneumonia No fibroid lung Other: Not pregnant or nursing Fertile patients must use effective contraception No psychiatric illness No malabsorption disorder No uncontrolled infection No uncontrolled diabetes mellitus No prior or concurrent malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No chronic steroid therapy (except steroids for adrenal failure or hormones for non-disease related conditions) Radiotherapy: No prior pelvic or mediastinal radiotherapy Surgery: Not specified Other: No concurrent anticonvulsants

• BACKGROUNDBlackstock 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. PMID 16365181
• RESULTNiell 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. PMID 15923572
• RESULTNiell 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.
• DERIVEDMarzano L, Darwich AS, Dan A, Tendler S, Lewensohn R, De Petris L, Raghothama J, Meijer S. Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study. Clin Transl Sci. 2024 Aug;17(8):e13909. doi: 10.1111/cts.13909. PMID 39113428
• DERIVEDVentz 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. PMID 36184621