Redefining FOLFIORINOX for Older Adults with Pancreatic Cancer

Sponsor: Fox Chase Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05360732

Provider View

This study is exploring a new treatment approach for older adults with newly diagnosed metastatic pancreatic cancer. It aims to assess the safety and side effects of alternating chemotherapy regimens, FOLFOX and FOLFIRI, in patients over 65.

Patient Parameters

Program Overview

The study is testing a new way to treat older adults with pancreatic cancer that has spread and hasn't been treated before. It involves alternating two chemotherapy treatments, FOLFOX and FOLFIRI, to see if they are safe and manageable for patients over 65. The treatment will be given in outpatient settings, and patients will be monitored using a FitBit to track their daily activity, along with blood tests and scans to check the cancer's progress. The study will include 37 patients, and their response to treatment will be evaluated every 8 weeks using CT scans.

Description

This clinical trial is designed to test the safety and side effects of alternating two chemotherapy regimens, FOLFOX and FOLFIRI, in older adults with newly diagnosed metastatic pancreatic cancer. The study will take place in multiple centers and will involve 37 patients aged 65 and older. Patients will receive treatment in an outpatient setting, and their daily activity will be monitored using a FitBit. Blood tests and CT scans will be used to track the cancer's progress and any side effects. The study will assess whether this treatment approach is feasible and effective for older adults. Patients will receive treatment every 28 days, alternating between FOLFOX and FOLFIRI, until the cancer progresses or other conditions apply. The study will be reviewed for effectiveness after 20 patients have been treated.

Eligibility Criteria

Inclusion Criteria

  • Age 65 years or older
  • Newly diagnosed and untreated pancreatic cancer that has spread, with at least one measurable tumor
  • Good overall health with a performance status of 0-2
  • Previous surgery, chemotherapy, or radiation allowed if completed within specific timeframes
  • Adequate blood cell counts and organ function
  • Fluent in English and willing to undergo a comprehensive geriatric assessment
  • Willing to use effective contraception if sexually active
  • Able to understand and sign informed consent
  • Open to all genders, races, and ethnicities

Exclusion Criteria

  • Different types of pancreatic cancer (endocrine or acinar)
  • Previous chemotherapy for metastatic or inoperable cancer
  • Recent radiation therapy within 2 weeks
  • Previous investigational therapy for metastatic pancreatic cancer
  • Known brain metastases
  • Immune deficiency or certain viral infections (HIV, hepatitis B or C)
  • Uncontrolled illnesses or psychiatric conditions
  • Active cancer within 2 years without treatment
  • Severe nerve damage or chronic diarrhea
  • Issues identified in the geriatric assessment, such as frequent falls or low BMI

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