Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00544193

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 I

MedlinePlus related topics: Cancer Gallbladder Cancer Intestinal Cancer Pancreatic Cancer Radiation Therapy Stomach Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

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

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 ]

Estimated Enrollment:	15
Study Start Date:	December 1997

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

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

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Stephen I. Shibata, MD

Beckman Research Institute

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000567461, CHNMC-97087
Study First Received:	October 13, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00544193 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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
unresectable extrahepatic bile duct cancer
small intestine adenocarcinoma
stage IV pancreatic cancer

Study placed in the following topic categories:

Antimetabolites
Gallbladder Diseases
Immunologic Factors
Gastrointestinal Diseases
Pancreatic Neoplasms
Bile Duct Cancer, Extrahepatic
Pancrelipase
Ileal Diseases
Duodenal Neoplasms
Stomach Diseases
Ileal Neoplasms
Stomach Neoplasms
Biliary Tract Diseases
Gemcitabine
Duodenal Diseases

Endocrine Gland Neoplasms
Jejunal Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Endocrine System Diseases
Intestinal Diseases
Immunosuppressive Agents
Antiviral Agents
Intestinal Neoplasms
Recurrence
Gall Bladder Cancer
Digestive System Diseases
Radiation-Sensitizing Agents
Bile Duct Diseases
Gastrointestinal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Gallbladder Diseases
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Pancreatic Neoplasms
Physiological Effects of Drugs
Ileal Diseases
Duodenal Neoplasms
Neoplasms by Site
Stomach Diseases
Ileal Neoplasms

Jejunal Diseases
Therapeutic Uses
Stomach Neoplasms
Biliary Tract Diseases
Gemcitabine
Duodenal Diseases
Endocrine Gland Neoplasms
Jejunal Neoplasms
Digestive System Neoplasms
Biliary Tract Neoplasms
Endocrine System Diseases
Enzyme Inhibitors
Intestinal Diseases
Immunosuppressive Agents
Antiviral Agents

ClinicalTrials.gov processed this record on May 06, 2009