SWOG clinical trial number
S0327
A Phase II Trial of PS-341 (NSC-681239) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer.
Abbreviated Title
PS-341/Platinum-treated/Extensive SCLC
Pts must have histologic/cystologically-confirmed SCLC, extensive disease (independent pathologic review in case of sputum cytology only); pts must not have prior malignancy except except treated basal cell or squamous cell skin cancer, in situ cervical, Stage I or II cancer in complete remission or disease-free from any cancer for 5 years; pts must have measurable disease per RECIST criteria and evidence of disease on X-ray, CT, MRI; ANC greater than 1,500/mm3 and platelets greater than 100, 000/mm3; pts must have been previously treated with platinum-based regimen and have data regarding initial best response and duration of response and time to progression; pts must not have symptomatic brain or leptomeningeal metastases; pts must not be receiving coricosteroids nor enzyme-inducing anticonvulsants necessary to control symptoms; pts may have received previous radiation therapy, but therapy must have been completed at least 3 weeks prior to registration; pt must not have plans for concurrent RT to measurable lesions; measurable disease inside RT port is allowed if there is demonstrated progression; serum creatinine must be less than IULN or CrCl greater than 60 cc/min; pts must have less than Grade 1 symptomatic neuropathy-sensory; Zubrod PS 0-1; must be 18 years of age or older; pts must not be pregnant or nursing women
2013
Disease control rate at 8 weeks predicts subsequent survival in platinum-treated extensive stage small cell lung cancer (ES-SCLC): a patients level analysis of SWOG trials
P Lara;J Moon;M Reddman;K Kelly;J Allen;B Gitlitz;PC Mack;D Gandara Journal of Thoracic Oncology 8(suppl. 2): abstr. MO13.01; the 15th World Conference on Lung Cancer, October 2013, Sydney, Australia
2006
Bortezomib (PS-341) in relapsed or refractory extensive stage small cell lung cancer: a Southwest Oncology Group Phase II Trial (S0327)
PN Lara;K Chansky;AM Davies;WA Franklin;PH Gumerlock;PP Guaglianone;JN Atkins;NC Farneth;PC Mack;JJ Crowley;DR Gandara Journal of Thoracic Oncology 1(9):996-1001
2005
The proteasome inhibitor PS-341 (bortezemib) in platinum (plat)-treated extensive-stage small cell lung cancer (E-SCLC): a SWOG (0327) phase II trial
J Johl;K Chansky;PN Lara;AM Davies;R Bold;DR Gandara Proc of the ASCO, JCO 23(16S):632s (#7047)
