A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

Brief Summary

Official Title: “A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers”

To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: September 2010

Interventions Used in this Clinical Trial

  • Drug: Gemcitabine
  • Drug: Docetaxel
  • Radiation: Radiation

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1
    • Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)

Outcome Measures for this Clinical Trial

Primary Measures

  • To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
    • Time Frame: 1 month after completion of treatment
      Safety Issue?: No

Secondary Measures

  • To describe the toxicities associated with chemoradiation with sequential gemcitabine and docetaxel and 5FU in patients with pancreaticobiliary cancers.
    • Time Frame: 30 days after completion of treatment
      Safety Issue?: Yes
  • To describe the overall survival and disease-free survival in patients treated with adjuvant chemoradiation with sequential gemcitabine/docetaxel and 5FU.
    • Time Frame: 5 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
  • Patients must be 18 years or older.
  • Patients must have a NCI CTC Performance Status of 0-2.
  • Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
  • At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
  • Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for >5years
  • Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
  • Initial Required Laboratory Values:
  • Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
  • Serum creatinine should be ≤ 2 mg/dL.
  • Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
  • Serum transaminases should be ≤ 5-fold the institutional upper limits.
  • Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
  • Patients must be able to sign an informed consent.

Exclusion Criteria

  • None

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benjamin Tan, M.D., Principal Investigator, Washington University School of Medicine

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00660699