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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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


- Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year
survival, in patients with locally advanced pancreatic cancer.

- Determine the toxicity of this regimen in these patients.

- Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive
gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the
first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy,
patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats
every 28 days for a total of 3 courses in the absence of disease progression or unacceptable

Quality of life is assessed at baseline, at completion of radiotherapy, at completion of
chemotherapy, and 3 months after completion of therapy.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28

Inclusion Criteria


- Histologically confirmed unresectable adenocarcinoma of the pancreas

- No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin

- Prior subtotal resection or gross residual disease

- No microscopic residual disease only

- No metastatic disease outside of planned study radiotherapy field



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST no greater than 3 times ULN


- Creatinine no greater than 1.5 times ULN


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to maintain adequate oral nutrition

- No significant infection

- No other medical condition that would preclude study

- No other malignancy within the past 5 years except non-melanoma skin cancer

- No significant nausea or vomiting


Biologic therapy:

- No prior or concurrent biologic therapy


- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No prior radiotherapy that would overlap planned study radiotherapy fields


- See Disease Characteristics

- At least 21 days since prior laparotomy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael G. Haddock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

September 2001

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • 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 - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
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
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
Medcenter One Health System Bismarck, North Dakota  58501
CentraCare Health Plaza Saint Cloud, Minnesota  56303
Altru Cancer Center Grand Forks, North Dakota  58206