- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003157
Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
A Phase I Study of Gemcitabine, Cisplatin, and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in treating patients who have cancer of the pancreas or stomach.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and cisplatin that can be administered during a standard course of radiation therapy for patients with unresectable or locally recurrent pancreatic and gastric cancer. II. Describe the tolerance of gemcitabine, cisplatin, and radiation therapy in this patient population. III. Seek preliminary evidence of the therapeutic activity of this regimen in this patient population as measured by survival.
OUTLINE: This is a dose escalation study. Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly on Tuesday and Friday over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. The dose limiting toxicity (DLT) is defined as the dose at which at least 2 of 6 patients experience unacceptable toxic effects. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
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Illinois
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, United States, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, United States, 56303
- CentraCare Clinic
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, United States, 68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Medcenter One Health System
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Grand Forks, North Dakota, United States, 58201
- Altru Health Systems
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Ohio
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City, South Dakota, United States, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, United States, 57105-1080
- CCOP - Sioux Community Cancer Consortium
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven unresectable (including incomplete resections) or locally recurrent pancreatic or gastric cancer No evidence of metastases outside of the planned radiation field No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal limits Alkaline phosphatase no greater than 3.0 times upper limit of normal (ULN) AST no greater than 3.0 times ULN Renal: Creatinine no greater than 1.3 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No significant infection or medical illness No significant nausea or vomiting At least 1200 calories per day of oral nutrition
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent biologic therapy Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy (except focal fields for skin cancer that do not overlap with planned radiotherapy fields) Surgery: At least 21 days since laparotomy surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: radiation + gemcitabine + cisplatin
Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone.
Radiation therapy is administered for a total of 5.5 weeks.
Patients receive intravenous gemcitabine twice weekly over the first 3 weeks of radiotherapy.
Cisplatin is administered intravenously twice weekly following gemcitabine therapy.
Three patients are treated at each dose level.
Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up.
Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects.
Patients experiencing toxic effects and no disease progression are retreated at a lower dose.
Patients are followed every 3 months for the first 2 years then every 6 months for the next year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose
Time Frame: Up to 3 years
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Up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: Up to 3 years
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Up to 3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: James A. Martenson, MD, Mayo Clinic
Publications and helpful links
General Publications
- Martenson JA Jr, Viglitotti AG, Geeraerts LH, et al.: Phase I study of twice weekly gemcitabine (GEM) and cisplatin (CDDP) during radiation therapy (RT) for advanced pancreas and gastric cancer: a progress report. [Abstract] Proceedings of the American Society of Clinical Oncology A-2305, 2001.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Stomach Neoplasms
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- NCCTG-964352
- CDR0000065949 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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