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Status:

TERMINATED

Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Lead Sponsor:

Andrew Ko

Collaborating Sponsors:

Eli Lilly and Company

Taiho Pharmaceutical Co., Ltd.

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to can...

Detailed Description

OBJECTIVES: Primary * Correlate intratumoral expression level of ribonucleotide reductase subunit 1 (RRM1) with response to gemcitabine hydrochloride therapy in patients with locally advanced unrese...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Adenocarcinoma of the pancreas that is already or will be histologically or cytologically proven.
  • Patients must have either locally advanced (unresectable) or metastatic disease.
  • Radiographically measurable disease is not required.
  • No prior therapy for advanced pancreatic cancer. Treatment given in the adjuvant setting (radiation and/or chemotherapy, given either concurrently or systemically) does not count as prior therapy as long as progressive disease occurs \> 6 months following completion of treatment.
  • Greater than or equal to 18 years of age.
  • ECOG performance status of 0 or 1 (See Appendix D).
  • Laboratory criteria:
  • ANC \> 1500/µL
  • Platelet count \> 100,000/µL
  • Hemoglobin \> 9 g/dL (may be transfused or receive epoetin alfa to maintain or exceed this level)
  • INR \< 1.5 (except those subjects who are receiving full-dose warfarin
  • Total bilirubin \< 2.0 mg/dL
  • AST or ALT \< 5 times upper limit of normal for subjects with documented liver metastases; \< 2.5 times the upper limit of normal for subjects without evidence of liver metastases
  • Serum creatinine \< 2.0 mg/dL
  • Serum CA19-9 \> 2X upper limits of normal.
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • Women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards.
  • Exclusion criteria
  • Inability to comply with study and/or follow-up procedures
  • Disease determined to be not amenable to biopsy upon review of radiographs by the oncologist and/or interventional radiologist.
  • Clearly resectable disease in a patient who is an appropriate operative candidate.
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
  • Prior systemic therapy for advanced pancreatic cancer
  • Pregnant (positive pregnancy test) or lactating
  • Use of anti-neoplastic or anti-tumor agents not part of the study therapy, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy, is not permitted while participating in this study.
  • Use of concurrent investigational agents is not permitted.
  • S-1 Specific Exclusion Criteria
  • Is receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
  • Sorivudine, brivudine, uracil, dipyridamole, cimetidine, and folinic acid (may enhance S-1 activity).
  • Allopurinol (may diminish S-1 activity).
  • Phenytoin (S-1 may enhance phenytoin activity).
  • Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 and flucytosine activity).
  • Pilocarpine (may inhibit cytochrome P-450 enzyme 2A6 activity).

Exclusion

    Key Trial Info

    Start Date :

    January 22 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 20 2010

    Estimated Enrollment :

    21 Patients enrolled

    Trial Details

    Trial ID

    NCT00429858

    Start Date

    January 22 2007

    End Date

    January 20 2010

    Last Update

    September 18 2020

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of California, San Francisco

    San Francisco, California, United States, 94143

    2

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231-2410