Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
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 |
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 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:
|
Stomach Neoplasms Pancreatic Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases Bile Duct Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013