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A Phase I Trial of Combined Modality Gemcitabine Plus Radiation Therapy for Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

A Phase I Trial of Combined Modality Gemcitabine Plus Radiation Therapy for Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma


OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine in combination with
radiation therapy to patients with locally advanced and/or unresectable adenocarcinoma of
the pancreas. II. Determine the dose limiting toxic effects of this combination therapy in
these patients. III. Evaluate the ability of these patients to tolerate induction and then
maintenance therapy with gemcitabine preceding and following combination therapy. IV.
Evaluate the efficacy (response rate, pattern of failure, and survival) of this combination
therapy in these patients.

OUTLINE: This is a dose escalation study of gemcitabine. Part I: Patients receive
gemcitabine as a continuous infusion over 30 minutes once weekly for 3 weeks followed by 1
week of rest. Part II: Gemcitabine IV is administered as a 30 minute infusion twice a week
(Monday and Thursday) for 5-6 weeks. Patients receive radiation therapy 5 days a week for
5-6 weeks. In the absence of dose-limiting toxicity (DLT) in the first 6 patients treated,
subsequent cohorts of 6 patients each receive escalating doses of gemcitabine on the same
schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation
ceases and the next lower dose is declared the maximum tolerated dose. Part III: In the
absence of toxicity and disease progression, patients continue gemcitabine for 3 additional
courses. Maintenance gemcitabine starts 4 weeks after the completion of radiation therapy
and is administered once weekly for 3 weeks followed by 1 week of rest. Patients are
followed until death.

PROJECTED ACCRUAL: This study will accrue 15-30 patients in approximately 24 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven locally advanced and/or
unresectable adenocarcinoma of the pancreas No metastatic disease No completely resected
pancreatic cancer

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% OR ECOG
0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine no greater than
1.5 mg/dL Cardiovascular: No congestive heart failure No New York Heart Association class
III and IV heart disease Other: Not pregnant No concurrent medical problems that would
increase the side effects or morbidity of chemoradiation No concurrent medical condition
that would make patient ineligible to receive external beam radiation such as: Crohn's
disease Inflammatory bowel disease No active infection requiring systemic antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
gemcitabine No prior chemotherapy for pancreatic cancer Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy to the pancreas Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Paul Kelsen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-019

NCT ID:

NCT00003426

Start Date:

April 1998

Completion Date:

March 2002

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021