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A Phase I Study of Gemcitabine, Cisplatin, and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer

Phase 1
18 Years
Not Enrolling
Gastric Cancer, Pancreatic Cancer

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Trial Information

A Phase I Study of Gemcitabine, Cisplatin, and Radiation Therapy in Patients With Locally Advanced Pancreatic and Gastric Cancer

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

James A. Martenson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Pancreatic Cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Stomach Neoplasms
  • Pancreatic Neoplasms



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