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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Stanley E. Order, MD, ScD, FACR

Investigator Role:

Study Chair

Investigator Affiliation:

Center for Molecular Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000064415

NCT ID:

NCT00002689

Start Date:

September 1995

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms

Name

Location

Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Center for Molecular MedicineGarden City, New York  11530