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)
18 Years
N/A
Both
Lung Cancer
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)
OBJECTIVES:
Primary
- 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.
Secondary
- 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
progression.
PROJECTED ACCRUAL: A total of 6-60 patients will be accrued to this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
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
completion
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent biologic response modifiers
Chemotherapy
- 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
S-1
Endocrine therapy
- See Disease Characteristics
- No concurrent endocrine therapy
Radiotherapy
- 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
Surgery
- Not specified
Other
- 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:
Interventional
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:
No
Principal Investigator
Dawn Buchanan
Investigator Role:
Principal Investigator
Investigator Affiliation:
Taiho Pharma U.S.A., Incorporated
Authority:
United States: Federal Government
Study ID:
CDR0000442390
NCT ID:
NCT00227578
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
Name | Location |
|---|---|
| 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 |
