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Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer, Pancreatic Cancer

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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 HospitalGoshen, Indiana  46526