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S-1 as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Quintiles
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00227604
  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: S-1
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Pancrelipase Ultrase S 1 (Combination)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Detailed Description:

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227604

  Show 27 Study Locations
Sponsors and Collaborators
Quintiles
Investigators
Principal Investigator: Dawn Buchanan Taiho Pharma U.S.A., Incorporated
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000442387, QUINT-TPU-S1201, TAIHO-QUINT-TPU-S1201
Study First Received: September 26, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00227604  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Pancrelipase
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009