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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
N/A
Not Enrolling
Both
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


OBJECTIVES:

- 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
toxicity.

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
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

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

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

Hepatic:

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

- AST no greater than 3 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior or concurrent biologic therapy

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy that would overlap planned study radiotherapy fields

Surgery:

- See Disease Characteristics

- At least 21 days since prior laparotomy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael G. Haddock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069026

NCT ID:

NCT00026403

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303
Altru Cancer CenterGrand Forks, North Dakota  58206