Full Text View
Tabular View
No Study Results Posted
Related Studies
Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003157
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Pancreatic Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of Gemcitabine, Cisplatin, and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer

Resource links provided by NLM:


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

Study Start Date: February 1998
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.

PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003157

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic
Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, North Dakota
Altru Health Systems
Grand Forks, North Dakota, United States, 58201
Medcenter One Health System
Bismarck, North Dakota, United States, 58501
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: James A. Martenson, MD Mayo Clinic
  More Information

Additional Information:
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 ID Numbers: CDR0000065949, NCCTG-964352
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003157     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV gastric cancer
recurrent gastric cancer
recurrent pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents
Pancrelipase
Recurrence
Digestive System Diseases
Stomach Diseases
Radiation-Sensitizing Agents
Cisplatin
Stomach Neoplasms
Gastrointestinal Neoplasms
Pancreatic Diseases
Stomach Cancer
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Stomach Diseases
Neoplasms by Site
Cisplatin
Stomach Neoplasms
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Digestive System Neoplasms
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009