An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
18 Years
N/A
Both
Lung Cancer
Trial Information
An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
OBJECTIVES:
Primary
- Determine the antitumor activity of S-1 as second-line therapy, in terms of overall
response rate, in patients with unresectable or recurrent stage IIIB or IV non-small
cell lung cancer.
Secondary
- Determine the duration of response, time to tumor progression, and overall survival of
patients treated with this drug.
- Determine the safety of this drug in these patients.
- Correlate S-1 plasma levels (components and metabolites) with safety and efficacy
parameters in patients treated with this drug.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive oral S-1 twice daily on days 1-14. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 weeks until progressive
disease and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 30-95 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically and/or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB disease with pleural or pericardial effusion
- Stage IV disease
- Unresectable or recurrent disease
- No mixed forms with small cell lung cancer
- Must have received 1 prior first-line combination chemotherapy (platinum- or
non-platinum-based) regimen
- 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 metastasis
- No leptomeningeal metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver
metastasis)
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- 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
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after study
participation
- No other active malignancy
- No psychiatric disorder or condition, severe acute or chronic medical condition, or
laboratory abnormality that would preclude study compliance
- No known HIV- or AIDS-related illness
- Able to take oral medication
- No known neuropathy ≥ grade 2
- No chronic nausea, vomiting, and/or diarrhea
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 3 weeks since prior immunotherapy or biologic therapy
- No concurrent immunotherapy
- No concurrent biologic response modifiers
Chemotherapy
- See Disease Characteristics
- No prior first-line treatment with S-1 for NSCLC
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy
- No other fluoropyrimidine-group antineoplastic agent within 7 days after the last
dose of S-1
Endocrine therapy
- See Disease Characteristics
- At least 3 weeks since prior hormonal therapy
- No concurrent endocrine therapy
Radiotherapy
- More than 2 weeks since prior radiotherapy
- Prior radiotherapy to a target lesion allowed provided the following criteria are
met:
- No radiotherapy within the past 3 months
- Evidence of progressive disease after radiotherapy
- Target lesion is not the only site of measurable disease
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 3 weeks since prior therapy for NSCLC
- At least 30 days since prior investigational agents
- No prior second-line therapy for NSCLC
- No other concurrent participation in another clinical trial
- No other concurrent investigational agent
- No concurrent administration of any of the following:
- Sorivudine
- Uracil
- Cimetidine
- Leucovorin calcium
- Dipyridamole
- Allopurinol
- Phenytoin
- Flucytosine
- No other concurrent drugs that may interact with S-1
- No other concurrent anticancer therapy
- No flucytosine within 7 days after the last dose of S-1
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate by CT scan and physical exam at the end of every even course or every 6 weeks until progressive disease (PD) or initiation of new anticancer therapy
Safety Issue:
No
Principal Investigator
Dawn Buchanan
Investigator Role:
Principal Investigator
Investigator Affiliation:
Taiho Pharma U.S.A., Incorporated
Authority:
United States: Federal Government
Study ID:
CDR0000442391
NCT ID:
NCT00227552
Start Date:
August 2005
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| New York Medical College | Valhalla, New York 10595 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
| Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Florida Cancer Institute - New Port Richey | New Port Richey, Florida 34655 |
| Associates in Oncology and Hematology | Chattanooga, Tennessee 37404 |
| Charleston Cancer Center | Charleston, South Carolina 29406 |
| Hematology Oncology Life Center | Alexandria, Louisiana 71301 |
| Compassionate Cancer Care Medical Group Incorporated - Fountain Valley | Fountain Valley, California 92708 |
| Western Hematology and Oncology Associates, PC | Lakewood, Colorado 80215 |
| Northwestern Connecticut Oncology Hematology Associates - Sharon | Sharon, Connecticut 06069 |
| Eastern Oncology Hematology | Greenville, North Carolina 27834 |
| New Bern Cancer Care | New Bern, North Carolina 28560 |
| Signal Point Hematology Oncology Incorporated | Middletown, Ohio 45042 |
| Vita Hematology Oncology at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
