A Phase 1 interventional study of gemcitabine hydrochloride and polymerase chain reaction in Extrahepatic Bile Duct Cancer, Gallbladder Cancer and Gastric Cancer, sponsored by City of Hope Medical Center. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
220 studies on the registry are indexed under Bile Duct Neoplasms; 44 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 164 interventional studies indexed under Bile Duct Neoplasms.
Browse Bile Duct Neoplasms studies →City of Hope Medical Center is the lead sponsor of 674 studies on the registry; 178 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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DISEASE CHARACTERISTICS:
Diagnosis of any of the following upper gastrointestinal malignancies:
Localized pancreatic adenocarcinoma
Locally advanced biliary, gallbladder, or ampullary adenocarcinoma
Histologically confirmed locally advanced gastric adenocarcinoma
Histologically confirmed locally advanced duodenal cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Feasibility
Tolerance
Measurement of biochemical parameters in tumors that may correlate with the effectiveness of therapy
No study locations are listed for this record.
The record gives a start of Dec 1997, a primary completion of Aug 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gemcitabine