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An Open Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

An Open Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)



- Determine the antitumor activity, in terms of overall response rate, of S-1 and
cisplatin in patients with unresectable stage IIIB or IV non-small cell lung cancer.


- Determine the duration of response and time to progression in patients treated with
this regimen.

- Determine the safety profile of this regimen in these patients.

- Correlate the S-1 (components and metabolites) plasma levels with safety and efficacy
parameters in patients treated with this regimen.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive oral S-1 twice daily on days 1-14 and cisplatin IV over 1-3 hours on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed every 6 weeks until disease

PROJECTED ACCRUAL: A total of 6-60 patients will be accrued to this study.

Inclusion Criteria


- Histologically and/or cytologically confirmed non-small cell lung cancer (NSCLC)
meeting 1 of the following criteria:

- Stage IIIB disease with pleural effusion or pericardial effusion

- Stage IV disease

- Unresectable disease

- No mixed histologies of small cell lung cancer

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- No symptomatic, uncontrolled (by corticosteroids) brain metastases

- No leptomeningeal metastasis



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL


- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver

- Bilirubin ≤ 1.5 times ULN


- Creatinine clearance ≥ 60 mL/min


- No myocardial infarction within the past 6 months

- No severe or unstable angina

- No New York Heart Association class III or IV congestive heart failure


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study

- No known HIV- or AIDS-related illness

- No known hypersensitivity to cisplatin

- Able to take oral medication

- No other active malignancy

- No peripheral neuropathy > grade 2

- No chronic nausea, vomiting, and/or diarrhea

- No psychiatric disorder that would preclude study compliance

- No other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may preclude study compliance


Biologic therapy

- No concurrent immunotherapy

- No concurrent biologic response modifiers


- More than 12 months since prior cytotoxic chemotherapy except for adjuvant or
neoadjuvant therapy for NSCLC

- No prior cisplatin as neoadjuvant and/or adjuvant chemotherapy with a cumulative dose
> 300 mg/m^2

- No other concurrent chemotherapy

- No fluoropyrimidine-group antineoplastic agents within 7 days after the last dose of

Endocrine therapy

- See Disease Characteristics

- No concurrent endocrine therapy


- More than 2 weeks since prior radiotherapy

- No prior radiotherapy to a target lesion unless there is subsequent evidence of
disease progression and it is not the only site of measurable disease

- No concurrent radiotherapy


- Not specified


- More than 12 months since prior adjuvant or neoadjuvant therapy

- More than 30 days since prior investigational agents

- No other concurrent investigational agent

- No concurrent enrollment in another clinical trial

- No other concurrent anticancer therapy

- No concurrent administration of any of the following:

- Sorivudine

- Uracil

- Cimetidine

- Leucovorin calcium

- Dipyridamole

- Allopurinol

- Phenytoin

- Flucytosine

- Aminoglycosides (avoid within 8 days after cisplatin)

- Amifostine

- No other concurrent drugs that interact with study treatment

- No flucytosine within 7 days after the last dose of S-1

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response by CT scan and physical exam at the end of every even course of treatment until disease progression or the initiation of new anticancer therapy

Safety Issue:


Principal Investigator

Dawn Buchanan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taiho Pharma U.S.A., Incorporated


United States: Federal Government

Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
City of Hope Comprehensive Cancer Center Duarte, California  91010
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Palm Beach Cancer Institute - West Palm Beach West Palm Beach, Florida  33401
Fountain Valley, California  92708
Kenmar Research Institute Los Angeles, California  90057
Lovelace Medical Center Albuquerque, New Mexico  87108
Associates in Oncology and Hematology Chattanooga, Tennessee  37404
Charleston Cancer Center Charleston, South Carolina  29406
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Hematology Oncology Life Center Alexandria, Louisiana  71301
Northwestern Connecticut Oncology Hematology Associates - Sharon Sharon, Connecticut  06069
Signal Point Hematology Oncology Incorporated Middletown, Ohio  45042
Vita Hematology Oncology at St. Luke's Hospital Bethlehem, Pennsylvania  18015