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

NCT00544193 | Completed Phase 1

• 3 other identifiers: 97087P30CA033572CHNMC-97087
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Feasibility

• Tolerance

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

Interventions

gemcitabine hydrochloride DRUG

polymerase chain reaction GENETIC

immunohistochemistry staining method OTHER

conventional surgery PROCEDURE

intraoperative radiation therapy RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms

Interventions

Gemcitabine; Polymerase Chain Reaction; Immunohistochemistry; Radiotherapy

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Therapeutics

Study Officials

• Stephen I. Shibata, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2007
• First Posted: October 16, 2007
• Study Start: December 1, 1997
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 8, 2015

Record last verified: 2015-06