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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001431
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.

Condition Intervention Phase
Gastrointestinal Neoplasms Pancreatic Neoplasms Drug: gemcitabine Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 20
Study Start Date: February 1995
Estimated Study Completion Date: November 2000
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001431


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001431     History of Changes
Other Study ID Numbers: 950075
95-C-0075
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: November 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Combined Modality
GI Cancer
Pancreatic Cancer
Radiotherapy

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Gemcitabine
Pancrelipase
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents