Redefining FOLFIORINOX in Older Pancreatic Cancer Patients

Launched by FOX CHASE CANCER CENTER · Apr 29, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Redefining FOLFIORINOX in Older Pancreatic Cancer Patients" is exploring a new treatment approach for older adults diagnosed with metastatic pancreatic cancer, which means the cancer has spread beyond the pancreas. This study is specifically looking at patients aged 65 and older who have not yet started treatment. The researchers want to see how well a combination of two chemotherapy regimens, FOLFOX and FOLFIRI, works for these patients and whether they can tolerate the side effects.

To be eligible for the trial, participants need to be at least 65 years old and have a confirmed diagnosis of pancreatic adenocarcinoma, which is the most common type of pancreatic cancer. They should also be in relatively good health, meaning they can carry out daily activities without much trouble. If you or a loved one qualify and choose to participate, you will receive the alternating chemotherapy treatments and be closely monitored for how well you respond and any side effects you might experience. It's also important to know that this study welcomes all genders and backgrounds, and aims to provide a tailored approach to treating pancreatic cancer in older adults.

Gender

ALL

Eligibility criteria

• Inclusion 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)/
• • o Alkaline Phasphatase ≤3 X ULN
• • o Or ≤5x ULN if liver metastasis present
• • 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.
• Exclusion Criteria:
• • 1. Endocrine or acinar pancreatic carcinoma
• • 2 Patients who have had any systemic chemotherapy in the metastatic or locally advanced inoperable setting (adjuvant or neoadjuvant therapy is allowed)
• • 3 Patients who have received radiation therapy within 2 weeks of signing consent.
• • 4 Patients who are currently receiving or have previously received any other investigational therapy for metastatic pancreatic cancer.
• • 5 Patients with known brain metastases - treated or untreated, are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events.
• • 6 Any patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known active or inactive hepatitis B, untreated HCV or treated HCV without a documented sustained virologic response are excluded from the study.
• • 7 Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• • 8 Patients with evidence of active malignancy within 2 years of enrollment without definitive treatment. Patients with localized prostate cancer status-post surgical resection or definitive radiation, localized ER/PR+/HER2- breast cancer status-post definitive local treatment with a low OncotypeDx® on adjuvant hormonal therapy, or local skin cancers that were previously resected will be eligible for inclusion. Patients with a history of in situ cancers treated with definitive local therapy will also be eligible.
• • 9 Patients with grade 3 or higher baseline sensory neuropathy
• • 10 Patients with chronic diarrhea (\>4 bowel movements/day) unresolved despite best supportive care for greater than 2 weeks.
• 11 Patients with any of the following results on the Comprehensive Geriatric Assessment:
• • \>2 falls in the past month
• • BMI \<18