Clinical trial NCT00002689: Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
Official title: Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Response rate
measure: Duration of remission
measure: Survival
Secondary outcomes:
measure: Patterns of failure
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital Cancer Center
state: Georgia
city: Garden City
country: United States
facility: Center for Molecular Medicine
state: New York
Study officials:
affiliation: Center for Molecular Medicine
name: Stanley E. Order, MD, ScD, FACR
role: STUDY_CHAIR
References: