Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer - Full Text View

Sponsored by:	Center for Molecular Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002689

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: dexamethasone Drug: fluorouracil Drug: phosphorus P32 Procedure: brachytherapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Fluorouracil Phosphorus Pancrelipase Ultrase Chromic phosphate P 32

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer

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

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Duration of remission [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patterns of failure [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	September 1995

Detailed Description:

OBJECTIVES:

Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.

OUTLINE: Patients are stratified according to prior therapy (yes vs no).

Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.

Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.

Patients are followed monthly for 1 year then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas
- Diameter no greater than 5 cm
- Volume no greater than 66 mL
No ascites (with or without tumor cells)
No endoscopically proven tumor penetration of duodenum or stomach

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 70-100%

Hematopoietic:

WBC at least 3,000/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

No hepatic disease
At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected
No vascular occlusion of portal system

Renal:

Creatinine no greater than 1.5 mg/dL
BUN no greater than 25 mg/dL

Other:

No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract

Surgery:

No complete surgical resection
No splenectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002689

Locations

United States, Georgia
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
United States, New York
Center for Molecular Medicine
Garden City, New York, United States, 11530

Sponsors and Collaborators

Center for Molecular Medicine

Investigators

Study Chair:

Stanley E. Order, MD, ScD, FACR

Center for Molecular Medicine

More Information

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

Study ID Numbers:	CDR0000064415, CMM-95079, CH/UMC-95079, NCI-V95-0760
Study First Received:	November 1, 1999
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00002689
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Dexamethasone
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Digestive System Diseases
Fluorouracil

Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Dexamethasone acetate
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics

Immunosuppressive Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009