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Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
gemcitabine hydrochloride
polymerase chain reaction
immunohistochemistry staining method
conventional surgery
intraoperative radiation therapy
radiation therapy
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring adenocarcinoma of the extrahepatic bile duct, adenocarcinoma of the gallbladder, adenocarcinoma of the pancreas, adenocarcinoma of the stomach, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, localized gallbladder cancer, recurrent gallbladder cancer, unresectable gallbladder cancer, recurrent gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, stage I gastric cancer, recurrent pancreatic cancer, small intestine adenocarcinoma, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of any of the following upper gastrointestinal malignancies:

    • Localized pancreatic adenocarcinoma

      • Stage I, II, or III disease
      • Parapancreatic node involvement and locally recurrent disease allowed

    • Locally advanced biliary, gallbladder, or ampullary adenocarcinoma

      • Stage II, III, or locally recurrent disease

    • Histologically confirmed locally advanced gastric adenocarcinoma

      • T3, T4, or node positive OR locally recurrent disease

    • Histologically confirmed locally advanced duodenal cancer

      • Stage II or III disease
  • Locally advanced, but unresectable cancers may be included on protocol if appropriate for intraoperative radiotherapy (IORT)
  • Other histologies may be considered for this protocol except for lymphoma, sarcoma, or neuroendocrine tumors
  • Patients with evidence of metastatic disease are eligible if there is significant local disease warranting surgery and IORT

PATIENT CHARACTERISTICS:

  • Karnofsky performance status > 60%
  • Life expectancy > 4 months
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Serum creatinine < 2.0 mg/dL
  • ALT < 3 x normal
  • Bilirubin < 2 x normal
  • Must be able to give voluntary informed consent
  • No severe intercurrent illness that would make the patient inappropriate for laparotomy or otherwise inappropriate for treatment on protocol
  • Prior history of malignancy allowed

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C)
  • Prior gemcitabine hydrochloride allowed

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Feasibility
    Tolerance
    Measurement of biochemical parameters in tumors that may correlate with the effectiveness of therapy

    Secondary Outcome Measures

    Full Information

    First Posted
    October 13, 2007
    Last Updated
    June 3, 2015
    Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00544193
    Brief Title
    Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer
    Official Title
    Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1997 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    August 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy in treating patients with locally advanced upper gastrointestinal cancer.
    Detailed Description
    OBJECTIVES: To determine the feasibility of combining preoperative or intraoperative gemcitabine hydrochloride with intraoperative radiotherapy. To determine the tolerance of gemcitabine hydrochloride given concurrently with external-beam radiotherapy. To measure biochemical parameters in tumors that may correlate with the effectiveness of therapy. OUTLINE: Patients receive gemcitabine hydrochloride IV 12-18 hours prior to planned surgery. All patients then undergo an exploratory laparotomy that may include tumor debulking, Whipple-type resection (pancreaticoduodenectomy), total pancreatectomy, gastrojejunostomy, total or partial gastrectomy, or cholecystectomy and en bloc resection depending on the extent of the disease. Patients with no metastatic disease beyond regional lymph nodes also undergo intraoperative radiotherapy. Beginning 2-6 weeks after surgery, patients undergo external-beam radiotherapy (EBRT) once a day 5 days a week for up to 7 weeks. Patients also receive escalating doses of gemcitabine hydrochloride IV at the beginning of each week of EBRT. Patients undergo tissue sample collection periodically for correlative studies. Samples are analyzed for thymidylate synthase (TS), ribonucleotide reductase (RR), excision-repair-cross-complementing (ERCC)-1 protein, deoxycytidine kinase mRNA. Biopsy tissues are also analyzed for gemcitabine triphosphate, dATP, and dCTP content. p53 status is assessed via immunohistochemistry and mRNA levels via quantitative polymerase chain reaction (PCR). After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then once a year thereafter.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Pancreatic Cancer, Small Intestine Cancer
    Keywords
    adenocarcinoma of the extrahepatic bile duct, adenocarcinoma of the gallbladder, adenocarcinoma of the pancreas, adenocarcinoma of the stomach, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, localized gallbladder cancer, recurrent gallbladder cancer, unresectable gallbladder cancer, recurrent gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, stage I gastric cancer, recurrent pancreatic cancer, small intestine adenocarcinoma, stage IV pancreatic cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine hydrochloride
    Intervention Type
    Genetic
    Intervention Name(s)
    polymerase chain reaction
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional surgery
    Intervention Type
    Radiation
    Intervention Name(s)
    intraoperative radiation therapy
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy
    Primary Outcome Measure Information:
    Title
    Feasibility
    Title
    Tolerance
    Title
    Measurement of biochemical parameters in tumors that may correlate with the effectiveness of therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Diagnosis of any of the following upper gastrointestinal malignancies: Localized pancreatic adenocarcinoma Stage I, II, or III disease Parapancreatic node involvement and locally recurrent disease allowed Locally advanced biliary, gallbladder, or ampullary adenocarcinoma Stage II, III, or locally recurrent disease Histologically confirmed locally advanced gastric adenocarcinoma T3, T4, or node positive OR locally recurrent disease Histologically confirmed locally advanced duodenal cancer Stage II or III disease Locally advanced, but unresectable cancers may be included on protocol if appropriate for intraoperative radiotherapy (IORT) Other histologies may be considered for this protocol except for lymphoma, sarcoma, or neuroendocrine tumors Patients with evidence of metastatic disease are eligible if there is significant local disease warranting surgery and IORT PATIENT CHARACTERISTICS: Karnofsky performance status > 60% Life expectancy > 4 months Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Serum creatinine < 2.0 mg/dL ALT < 3 x normal Bilirubin < 2 x normal Must be able to give voluntary informed consent No severe intercurrent illness that would make the patient inappropriate for laparotomy or otherwise inappropriate for treatment on protocol Prior history of malignancy allowed PRIOR CONCURRENT THERAPY: More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C) Prior gemcitabine hydrochloride allowed
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephen I. Shibata, MD
    Organizational Affiliation
    City of Hope Comprehensive Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer

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