Search / Trial NCT00001431

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of April 22, 2024

Completed

Keywords

Combined Modality Gi Cancer Pancreatic Cancer Radiotherapy

Description

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.

Gender

All

Eligibility 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.

Attachments

readout_NCT00001431_2024-04-22.pdf

4.5 MB

NCT00001431_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
3 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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