G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients

Phase 1/2 Completed 85 enrolled National Cancer Institute, Naples

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with extensive small cell lung cancer.

Timeline

Start: 2000-11
Primary completion: 2007-12
Completion: 2009-02

Publications

Results Gridelli C, Gallo C, Morabito A, Iaffaioli RV, Favaretto A, Isa L, Barbera S, Gamucci T, Ceribelli A, Filipazzi V, Maione P, Rossi A, Barletta E, Signoriello S, De Maio E, Piccirillo MC, Di Maio M, Rocco G, Vecchione A, Perrone F; G-STEP Investigators. Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STEP trial. J Thorac Oncol. 2012 Jan;7(1):233-42. doi: 10.1097/JTO.0b013e318233d6c2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	3.5 unknown	—
Subject	Carboplatin	Small molecule	4 unknown	—
Subject	Carboplatin	Small molecule	4.5 unknown	—
Subject	Cisplatin	Other / unclassified	50 mg/m2	—
Subject	Cisplatin	Other / unclassified	60 mg/m2	—
Subject	Cisplatin	Other / unclassified	70 mg/m2	—
Subject	Etoposide	Small molecule	60 mg/m2	—
Subject	Etoposide	Small molecule	70 mg/m2	—
Subject	Etoposide	Small molecule	80 mg/m2	—
Subject	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Vinorelbine	Small molecule	25 mg/m2	—

G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients

Summary

Timeline

Publications

Drugs

Indications