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8110 Gatehouse Road, Falls Church, VA 22042

Redefining The Use Of a FOLFIRINOX-Like Regimen In the Front Line In Older Patients With Metastatic Pancreatic Cancer (GI 170)

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General Information

Age Group

Adults ages 65 and older

Status

Recruiting

Protocol Number

U21-05-4460

Background Information

One of the standard FDA-approved regimens used to treat patients with metastatic pancreatic cancer is a combination of four chemotherapy drugs, 5-fluorouracil (5-FU), leucovorin, oxaliplatin, and irinotecan. These medications have been shown to be effective in treating pancreatic cancer that’s spread to other organs, but carry with it many side effects. Some patients over the age of 65 years are deemed ineligible to receive the regimen. The purpose of this research study is to find out if the study medications, 5-FU, oxaliplatin, and irinotecan can be given on an alternating schedule whereby two of the drugs are given at a time rather than all 3, switching off every other cycle to hopefully minimize side effects and maintaining the effect on the cancer. The alternating schedule employed in this study is investigational.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

Inova Schar Cancer Institute
3580 Joseph Siewick Drive
Fairfax, VA 22033

Eligibility Information

  • Age 65 years or older
  • Newly diagnosed and previously untreated, histologically or cytologically confirmed adenocarcinoma of the pancreas, with at least one site of metastatic disease (local recurrences after surgery allowed), with lesions that are measurable by RECIST v1.1 criteria. In patients with mixed histology tumors, the predominant feature must be adenocarcinoma
  • Be willing to undergo a Comprehensive Geriatric Assessment
  • Additional eligibility in protocol

Ineligibility Information

  • Endocrine or acinar pancreatic carcinoma
  • Patients who are currently receiving or have previously received any other investigational therapy for metastatic pancreatic cancer
  • Patients with known brain metastases
  • Known HIV-positive patients and those with known active or inactive hepatitis B, untreated HCV or treated HCV without a documented sustained virologic response
  • Additional ineligibility in protocol