Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002689
• Other study ID #: CMM-95079
• Secondary ID: CDR0000064415CH/
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 17, 2013
• Start date: September 1995
• Est. completion date: June 2007

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• dexamethasone

• fluorouracil

Radiation:
• brachytherapy

• phosphorus P32

• radiation therapy

Locations

Country	Name	City	State
United States	Northside Hospital Cancer Center	Atlanta	Georgia
United States	Center for Molecular Medicine	Garden City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Center for Molecular Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Primary	Duration of remission			No
Primary	Survival			No
Secondary	Patterns of failure			No