Redefining FOLFIORINOX in Older Pancreatic Cancer Patients

Description

This is a multi- centered two-stage Pilot Study assessing the tolerability and toxicity of an alternating regimen of FOLFOX and FOLFIRI for the treatment of newly diagnosed and untreated metastatic pancreatic cancer in patients over the age of 65 years.

Conditions

Metastatic Pancreatic Cancer

Study Overview

Study Details

Study overview

This is a multi- centered two-stage Pilot Study assessing the tolerability and toxicity of an alternating regimen of FOLFOX and FOLFIRI for the treatment of newly diagnosed and untreated metastatic pancreatic cancer in patients over the age of 65 years.

Redefining The Use Of A FOLFIRINOX-Like Regimen In the Front Line In Older Patients With Metastatic Pancreatic Cancer

Redefining FOLFIORINOX in Older Pancreatic Cancer Patients

Condition
Metastatic Pancreatic Cancer
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, 19111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 65 years or older
  • 2. The treating physician will use their discretion when assessing if the patient is eligible for this treatment.
  • 3. Patients must have 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.
  • 4. Eastern Cooperative Oncology Group Performance status of 0-2.
  • 5. Previous surgery, adjuvant chemotherapy and/or radiation therapy will be allowed, provided radiation therapy is completed at least 2 weeks prior to signing consent and adjuvant therapy was administered more than 6 months prior to signing consent.
  • 6. Patients must have bone marrow and organ function as defined below:
  • * Absolute Neutrophil Count ≥ 1,500/μL
  • * Platelets ≥ 100,000/μL
  • * Total Bilirubin ≤2 X ULN
  • * AST(SGOT)/ALT(SGPT)/
  • * Creatinine ≤2.0 mg/dL And
  • * eGFR (using Cockcroft Gault equation) \> 40ml/min
  • 7. Patients must be fluent in English and must be able and willing to undergo Comprehensive Geriatric Assessment
  • 8. Chemotherapy is harmful to the human fetus. For this reason, sexually active males with partners of childbearing potential must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study.
  • 9. Patients must demonstrate ability to understand and the willingness to sign a written informed consent document.
  • 10. Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.
  • 1. Endocrine or acinar pancreatic carcinoma
  • * \>2 falls in the past month
  • * BMI \<18

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fox Chase Cancer Center,

Study Record Dates

2025-09-01