S-1 as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy, such as S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well S-1 works as second-line therapy in treating patients with metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: tegafur-gimeracil-oteracil potassium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Metastatic Pancreatic Cancer |
- 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 [ Designated as safety issue: No ]
- Duration of 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 [ Designated as safety issue: No ]
- Progression-free survival by CT (with contrast) of the chest and abdomen at the end of every even course or every 6 weeks for up to 6 months [ Designated as safety issue: No ]
- Survival after disease progression monthly for up to 6 months from first day of treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 27 Study Locations| Principal Investigator: | Dawn Buchanan | Taiho Pharma U.S.A., Incorporated |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00227604 History of Changes |
| Other Study ID Numbers: | CDR0000442387, QUINT-TPU-S1201, TAIHO-QUINT-TPU-S1201 |
| Study First Received: | September 26, 2005 |
| Last Updated: | October 30, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Tegafur S 1 (combination) Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 13, 2013