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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00544193
First received: October 13, 2007
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Gastric Cancer
Pancreatic Cancer
Small Intestine Cancer
Drug: gemcitabine hydrochloride
Genetic: polymerase chain reaction
Other: immunohistochemistry staining method
Procedure: conventional surgery
Radiation: intraoperative radiation therapy
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • Tolerance [ Designated as safety issue: Yes ]
  • Measurement of biochemical parameters in tumors that may correlate with the effectiveness of therapy [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: December 1997
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544193

Sponsors and Collaborators
City of Hope Medical Center
Investigators
Study Chair: Stephen I. Shibata, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00544193     History of Changes
Other Study ID Numbers: 97087, P30CA033572, CHNMC-97087
Study First Received: October 13, 2007
Last Updated: November 21, 2012
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
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

Additional relevant MeSH terms:
Bile Duct Neoplasms
Gallbladder Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Biliary Tract Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gallbladder Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Stomach Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014