A Phase I Trial of Gemcitabine & Radiation in Locally NCT00001431

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00001431
Other study ID #	950075
Secondary ID	95-C-0075
Status	Completed
Phase	Phase 1
First received	November 3, 1999
Last updated	March 3, 2008
Start date	February 1995
Est. completion date	November 2000

Study information
Verified date	November 2000
Source	National Institutes of Health Clinical Center (CC)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Interventional

Clinical Trial Summary

Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	20
Est. completion date	November 2000
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gemcitabine

Locations
Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors *(1)*
Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,

References & Publications (2)

Morohoshi T, Held G, Klöppel G. Exocrine pancreatic tumours and their histological classification. A study based on 167 autopsy and 97 surgical cases. Histopathology. 1983 Sep;7(5):645-61. — View Citation

Rosenberg JM, Welch JP, Macaulay WP. Cancer of the head of the pancreas: an institutional review with emphasis on surgical therapy. J Surg Oncol. 1985 Mar;28(3):217-21. — View Citation

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

Clinical Trial Details — Status: Completed

Administrative data

Study information