ACTIVE_NOT_RECRUITING

Redefining FOLFIORINOX in Older Pancreatic Cancer Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-04-22

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05360732

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.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* \>2 falls in the past month * BMI \<18

Inclusion Criteria

Exclusion 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.

* \>2 falls in the past month
* BMI \<18

Contacts and Locations

Study Locations (Sites)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Fox Chase Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-22

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-04-22

Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Pancreatic Cancer