Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy in Advanced Non-Small Cell Lung Cancer

NCT00651833 | Completed Phase 2

• 1 other identifier: TPU-S1202
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether S-1 in combination with Cisplatin is effective as 1st 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) for a max of 6 cycles. Tumor assessments will be obtained at baseline and at the end of every even cycle.

Secondary Outcomes (3)

• To evaluate the safety profile of S-1

  AEs will be reported through follow-up (30 days after the last dose of study medication); blood/urine will be collected at baseline ; Days 8 and 15; w/in 24 hrs prior to study drug on Day 1 of each cycle after Cycle 1; at the end of study treatment.

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

  Each cycle will last 21 days (14 days treatment, 7 days recovery) for a max of 6 cycles. Following discont'n of treatment , pts will be followed for survival status every 2 mos following PD for up to 6 mos.

• 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) for a max of 6 cycles. 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)

1

EXPERIMENTAL

All patients will receive S-1 orally at a dose of 25 mg/m2 twice daily (BID) for 14 days followed by a 1-week recovery period, repeated every 3 weeks. Patient will also receive cisplatin, 75 mg/m2 as a 1- to 3-hour infusion on Day 1 of each cycle.

Drug: S-1

Interventions

S-1 DRUG

All patients will receive S-1 orally at a dose of 25 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 third stage only if 7/31 (23%) or more patients have achieved a confirmed response (CR or PR) in stages 1 and 2 combined.

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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. Patients with histologically and/or cytologically proven unresectable NSCLC stage IIIB with pleural effusion or pericardial effusion, or stage IV (mixed forms with small cell lung cancer are excluded).
• \. 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. 5. Is ≥ 18 years of age. 6. Has an ECOG performance status 0 or 1. 7. 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/minute (Cockcroft-Gault formula).
• \. 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 prior cytotoxic chemotherapy except for adjuvant or neo-adjuvant therapy for NSCLC beyond 12 months.
• Any radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
• Radiotherapy within the prior 2 weeks.
• Adjuvant or neo-adjuvant therapy within the past 12 months.
• Prior cisplatin as neo-adjuvant and/or adjuvant chemotherapy with cumulative dose \> 300 mg/m2.
• Any investigational agent, either concurrently or within the past 30 days.
• 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.
• Known neuropathy Grade 2 or higher.
• Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV.

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: October 1, 2006
• Study Completion: July 1, 2007
• Last Updated: September 3, 2024

Record last verified: 2024-08