Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas - Full Text View

Sponsor:	University of South Florida
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00079365

Purpose

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Fluorouracil may make the tumor cells more sensitive to radiation therapy. Brachytherapy uses radioactive material, such as phosphorus P32, placed directly into or near a tumor to kill tumor cells. Combining chemotherapy and external-beam radiation therapy with brachytherapy may kill more tumor cells.

PURPOSE: This randomized clinical trial is studying fluorouracil, gemcitabine, external-beam radiation therapy, and brachytherapy using phosphorus P32 to see how well they work compared to fluorouracil, gemcitabine, and external-beam radiation therapy in treating patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas (pancreatic cancer).

Condition	Intervention
Pancreatic Cancer	Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: brachytherapy Radiation: phosphorus P32 Radiation: radiation therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Primary Purpose: Treatment
Official Title:	A Randomized Trial Comparing 5-Fluorouracil, External Beam Radiation, and Gemcitabine With or Without P Radiopharmaceutical Therapy As A First Line Therapy in Patients With Locally/Regionally Advanced Non-Resectable Adenocarcinoma of the Pancreas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Fluorouracil Chromic phosphate P 32 Pancrelipase Gemcitabine Gemcitabine hydrochloride Ultrase Phosphorus

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2001

Detailed Description:

OBJECTIVES:

Primary

Compare the survival of patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas treated with fluorouracil, external beam radiotherapy, and gemcitabine with vs without brachytherapy with phosphorus P32 suspension.

Secondary

Compare time to disease progression, tumor response rate, and physical performance in patients treated with these regimens.
Compare the safety and tolerability of these regimens in this patient population.
Compare duration of response and time to treatment failure in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive phosphorus P32 suspension percutaneously under CT guidance on day 0 and at months 1, 2, 6, 7, and 8. Patients receive fluorouracil IV continuously on days 1-5 of weeks 1-6. Patients concurrently undergo external beam radiotherapy 5 days a week on weeks 1-6. At the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks. After a 1-week rest, patients then receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment repeats every 28 days.
Arm II: Patients receive fluorouracil and gemcitabine and undergo external beam radiotherapy as in arm I.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 24-30 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed pancreatic adenocarcinoma
- Locally or regionally advanced disease
Unresectable disease defined by the following:
- Invasion into a major vascular structure determined preoperatively by a CT scan, angiogram, or CT portogram or intraoperatively by surgeon
- Severe comorbidities precluding operation, such as congestive heart failure, coronary artery disease, or chronic obstructive pulmonary disease
Bidimensionally measurable disease by CT scan
No recurrent disease
No previously resected pancreatic cancer
No tumors of the pancreas not ductal in origin (e.g., islet cell tumors, lymphoma, or sarcoma)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count: ≥ 1,500/mm^3
Platelet count ≥ 50,000/mm^3
Hemoglobin ≥ 10 g/dL

Hepatic

Bilirubin < 2 times upper limit of normal (ULN)
AST and ALT < 5 times ULN
Alkaline phosphatase < 5 times ULN
Albumin ≥ 2.5 mg/dL

Renal

Creatinine ≤ 1.5 mg/dL

Cardiovascular

See Disease Characteristics

Pulmonary

See Disease Characteristics

Other

No other malignancy within the past 5 years except curatively resected basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or early stage prostate cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for pancreatic adenocarcinoma

Surgery

See Disease Characteristics

Other

No prior chromic phosphate P32 suspension (Phosphocol®)
At least 4 weeks since prior cytotoxic therapy for pancreatic adenocarcinoma
At least 4 weeks since prior investigational anti-tumoral agents
No other concurrent investigational agents
No other concurrent anticancer agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079365

Locations

United States, Florida
USF Physician's Group
Tampa, Florida, United States, 33606

Sponsors and Collaborators

University of South Florida

Investigators

Study Chair:

Alexander Rosemurgy, MD

University of South Florida

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000355400, USFPG-6034
Study First Received:	March 8, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00079365 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Pancrelipase
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type

Gastrointestinal Agents
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Fluorouracil
Pancreatic Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on March 18, 2010