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A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas


Phase 1
N/A
N/A
Not Enrolling
Both
Gastrointestinal Neoplasms, Pancreatic Neoplasms

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Trial Information

A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas


This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered
concurrently with radiation in patients with locally advanced or locally recurrent
pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a
standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the
first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be
assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity
grading system.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or
ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills
requirement.

Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct
extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon,
Peripancreatic tissue, Adjacent large vessels, Stomach.

Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.

No lymphomas or neuroendocrine tumors.

No peritoneal carcinomatosis.

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: More than 4 weeks since immunotherapy.

Chemotherapy:

No prior chemotherapy for newly diagnosed disease.

More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas,
mitomycin, or suramin).

Endocrine Therapy: More than 4 weeks since hormonal therapy.

Radiotherapy:

No prior radiotherapy for newly diagnosed disease.

No prior abdominal or pelvic radiotherapy.

More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for
locally advanced disease after resection allowed.

Surgery:

Prior resection allowed.

Biliary decompression or gastric bypass allowed.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0-2.

Hematopoietic:

ANC greater than 2,000/mm(3).

Platelets greater than 100,000/mm(3).

Hepatic: AST/ALT no greater than 2.5 times normal.

Renal:

Creatinine less than 1.5 mg/dL.

Creatinine clearance at least 60 mL/min,

Cardiovascular:

No myocardial infarction within 6 months.

No unstable angina.

No congestive heart failure (NYHA class III/IV).

OTHER:

HIV seronegative.

No medical or psychiatric contraindication to protocol therapy.

No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.

No pregnant or nursing women.

Adequate contraception required of fertile patients.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

950075

NCT ID:

NCT00001431

Start Date:

February 1995

Completion Date:

November 2000

Related Keywords:

  • Gastrointestinal Neoplasms
  • Pancreatic Neoplasms
  • Combined Modality
  • GI Cancer
  • Pancreatic Cancer
  • Radiotherapy
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Pancreatic Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892