Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
18 Years
N/A
Both
Metastatic Cancer, Pancreatic Cancer
Trial Information
Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
OBJECTIVES:
Primary
- Determine tumor response in patients with unresectable, newly diagnosed or recurrent
pancreatic cancer and liver metastases treated with selective internal radiotherapy
with yttrium Y 90 microspheres, selective external radiotherapy with tomotherapy, and
fluoroucacil.
- Determine hepatic and systemic toxicity of this regimen in these patients.
Secondary
- Determine the efficacy of this regimen, in terms of time to progression and survival,
in these patients.
OUTLINE: Patients receive fluorouracil IV continuously on days 1-4. Patients undergo
selective internal radiotherapy with yttrium Y 90 microspheres on day 2 and selective
external radiotherapy with tomotherapy on day 3.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic cancer with liver metastases
- Unresectable disease AND meets any of the following criteria:
- Newly diagnosed disease
- No prior treatment
- Received prior treatment and progressed
- Underwent prior pancreatectomy and progressed
- Liver-only disease (receives selective internal radiotherapy only)
- No known CNS metastases
- No known diffuse peritoneal metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Life expectancy > 3 months
- WBC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin < 2 mg/dL (without extrahepatic biliary obstruction)
- Albumin > 2 g/dL
- Creatinine < 2 mg/dL
- Not pregnant
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior surgery, chemotherapy, and biologic therapy allowed
- No prior external beam radiotherapy to liver or pancreatic bed
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response
Safety Issue:
No
Principal Investigator
Kenneth L. Pennington, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Goshen Health System
Authority:
United States: Federal Government
Study ID:
CDR0000530018
NCT ID:
NCT00436267
Start Date:
November 2006
Completion Date:
Related Keywords:
- Metastatic Cancer
- Pancreatic Cancer
- recurrent pancreatic cancer
- stage IV pancreatic cancer
- liver metastases
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
