Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer

NCT00652561 | Completed Phase 2

• 1 other identifier: TPU-S1203
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether S-1 is effective as 2nd line therapy in slowing tumor activity in patients with advanced non-small cell lung cancer. The study is also looking at the safety of S-1.

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall tumor response rate (ORR - the proportion of patients with objective evidence of PR or CR)

  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

Secondary Outcomes (3)

• To evaluate the duration of response (DR), and progression-free survival (PFS)

  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

  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

  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.

Study Arms (1)

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EXPERIMENTAL

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.

Drug: S-1

Interventions

S-1 DRUG

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

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Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Has given written informed consent. 2. Has histologically and/or cytologically proven unresectable or recurrent NSCLC stage IIIB with pleural effusion or pericardial effusion, or stage IV (mixed forms with small cell lung cancer are excluded).
• \. Has received prior 1st line chemotherapy combination (platinum or non-platinum-based) treatment and has not received any 2nd line therapy.
• \. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, ie, has at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral Computed Tomography (CT) scan.
• \. Is able to take medications orally. 6. Is ≥ 18 years of age. 7. Has an ECOG performance status 0 or 1. 8. Has adequate organ function as defined by the following criteria:
• AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis AST (SGOT) and ALT (SGPT) ≤ 5 x ULN.
• Total serum bilirubin of ≤ 1.5 x ULN.
• Absolute granulocyte count of ≥ 1,500/mm3.
• Platelet count ≥ 100,000/mm3.
• Hemoglobin of ≥ 9.0 g/dL.
• Calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula). 9. Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

• \. Has had treatment with any of the following within the specified time frame prior to study drug administration:
• Any investigational agent either concurrently or within the past 30 days.
• Any prior 1st line treatment with S-1 for NSCLC.
• Previous therapy for NSCLC within the past 21 days, including any chemotherapy, immunotherapy, biologic or hormonal therapy (6 weeks for nitrosureas or mitomycin C).
• Radiotherapy within the prior 2 weeks.
• Any radiation therapy to a target lesion within the past 3 months, unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
• Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study.
• \. Has a serious illness or medical condition(s) including, but not limited to, the following:
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• Other active malignancies.
• Symptomatic brain metastasis not controlled by corticosteroids.
• Leptomeningeal metastasis.
• Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV.
• Chronic nausea, vomiting, and/or diarrhea.
• Psychiatric disorder that may interfere with consent and/or protocol compliance.

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead
• Quintiles, Inc.: collaborator
• United BioSource, LLC: collaborator

MeSH Terms

Interventions

S 1 (combination)

Study Officials

• Fabio Benedetti, MD

  Taiho Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: February 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: September 3, 2024

Record last verified: 2024-08