An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Metastatic Pancreatic Cancer
OBJECTIVES:
Primary
- Determine the antitumor activity of S-1 as second-line therapy, in terms of overall
response rate, in patients with metastatic pancreatic cancer previously treated with
gemcitabine.
Secondary
- Determine the duration of response, time to tumor progression, and overall survival
rate in patients treated with this drug.
- Correlate changes in CA 19-9 with antitumor activity of this drug in these patients.
- Determine the effect of this drug on the clinical benefit parameters in these patients.
- Determine the safety of this drug in these patients.
- Correlate plasma drug levels with safety and efficacy of this drug in these patients.
OUTLINE: This is an open-label, non-randomized, 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 for up to 6 months.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
- Not amenable to curative radiotherapy or surgery
- Received first-line treatment with a gemcitabine-based regimen
- Measurable liver metastasis, defined as ≥ 1 unidimensionally measurable lesion ≥ 20
mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No symptomatic brain metastasis unless controlled by corticosteroids
- No uncontrolled ascites requiring drainage ≥ 2 times a week
- No leptomeningeal metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN (5 times ULN if due to liver metastases)
Renal
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- No myocardial infarction within the past 6 months
- No severe/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
completion of study treatment
- Able to take oral medications
- No known hypersensitivity to fluorouracil
- No other active malignancies
- No known HIV- or AIDS-related illness
- No other severe acute or chronic medical condition, psychiatric condition, or
laboratory abnormality that would preclude study participation
- No chronic diarrhea, constipation (uncontrolled by laxatives), nausea, or vomiting
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent biologic response modifiers
Chemotherapy
- See Disease Characteristics
- At least 2 weeks since prior first-line gemcitabine-based regimen
- No other concurrent chemotherapy
- No fluoropyrimidine-group antineoplastic drugs within 7 days after completion of
study treatment
Endocrine therapy
- See Disease Characteristics
- No concurrent endocrine therapy
Radiotherapy
- At least 2 weeks since prior radiotherapy
- No prior radiotherapy to a target lesion unless the following are true:
- There is 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 30 days since prior investigational agents
- No prior second-line therapy
- No concurrent investigational agents
- No concurrent drugs that may interact with S-1, including any of the following:
- Sorivudine
- Uracil
- Cimetidine
- Leucovorin calcium
- Dipyridamole
- Allopurinol
- Phenytoin
- Flucytosine
- No concurrent enrollment in another clinical study
- No other concurrent anticancer therapy
- No flucytosine within 7 days after completion of study treatment
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall tumor response by CT (with contrast) of the chest, abdomen, and pelvis and physical exam at the end of every even course or every 6 weeks for up to 6 months
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:
CDR0000442387
NCT ID:
NCT00227604
Start Date:
November 2004
Completion Date:
Related Keywords:
- Pancreatic Cancer
- recurrent pancreatic cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| Broward General Medical Center Cancer Center | Ft. Lauderdale, Florida 33316 |
| Comprehensive Cancer Institute | Huntsville, Alabama 35801 |
| Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
| Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
| Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
| New Mexico Cancer Care Associates | Santa Fe, New Mexico 87505-7670 |
| U.T. Cancer Institute at University of Tennessee Medical Center | Knoxville, Tennessee 37920-2911 |
| Palm Beach Cancer Institute - West Palm Beach | West Palm Beach, Florida 33401 |
| Fountain Valley, California 92708 | |
| Lovelace Medical Center | Albuquerque, New Mexico 87108 |
| Florida Cancer Institute - New Port Richey | New Port Richey, Florida 34655 |
| Hematology Oncology Associates, PC | Albuquerque, New Mexico 87106 |
| Associates in Oncology and Hematology - Medical Center Drive | Rockville, Maryland 20878 |
| Cancer Center of Indiana | New Albany, Indiana 47150 |
| Mary Crowley Medical Research Center at Sammons Cancer Center | Dallas, Texas 75246 |
| H. Clay Evans Johnson Cancer Center at Memorial Hospital | Chattanooga, Tennessee 37404 |
| Compassionate Cancer Care Medical Group Incorporated - Fountain Valley | Fountain Valley, California 92708 |
| Western Hematology and Oncology Associates, PC | Lakewood, Colorado 80215 |
| Eastern Oncology Hematology | Greenville, North Carolina 27834 |
| New Bern Cancer Care | New Bern, North Carolina 28560 |
| Signal Point Hematology Oncology Incorporated | Middletown, Ohio 45042 |
| East Bay Medical Oncology Hematology Associates | Concord, California 94520 |
