Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00652561|
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : March 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Advanced Non-Small Cell Lung Cancer||Drug: S-1||Phase 2|
Advanced non-small cell lung cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione [FT]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine [CDHP]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.
This is an open-label, multicenter, single-arm, 3-stage, Phase 2 study evaluating the efficacy and safety of single agent S-1 as 2nd line therapy for patients with advanced NSCLC. The 3 stages of this study correspond to a futility stage (stage 1), a decision stage (stage 2), and a stage for improvement of precision of ORR (stage 3).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2nd Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks.
All patients will receive S-1 orally at a dose of 30 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The study may go to the second stage only if the stage 2 criteria are met, where 3/30 (10%) or more patients must have achieved a confirmed response (CR or PR) in stage 1.The study may go to the third stage only if at least 8/50 patients (16%) must have achieved a confirmed response in stage 2
- Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR) [ Time Frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Tumor assessmentswill be obtained at baseline and at the end of every even cycle ]
- To evaluate the duration of response (DR), and progression-free survival (PFS) [ Time Frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. Pts will be followed for survival every 2 mos after PD for up to 12 mos from the date of enrollment of the last pt. ]
- To evaluate the safety profile of S-1 [ Time Frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death/removal from study. AEs reported through f/up; blood/urine collected at baseline, Days 8&15, w/in 24 hrs of drug on Day 1 of each cycle after Cycle 1, at end of treatment. ]
- To investigate the relationship of S-1 plasma levels (components and metabolites) with safety and efficacy parameters [ Time Frame: Each cycle will last 21 days (14 days treatment, 7 days recovery) until death or removal from study for any reason. s Blood samples to be obtained 1.5 ± 0.5 h, 5 ± 1 h, 7 ± 1 h postdose on Day 1 of Cycle 1 only. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652561
|Study Director:||Fabio Benedetti, MD||Taiho Oncology, Inc.|