FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: To determine the feasibility and safety of combining digoxin as a modulator of the hypoxia pathway in combination with FOLinic acid, 5-Fluorouracil, IRINotecan and OXaliplatin (FOLFIRINOX) in patients with resectable pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jean Grem, MD
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Camptothecin; Digoxin; Fluorouracil; Folic Acid; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of the pancreas. Patients must have resectable disease with no evidence of distant metastasis

2. Age: Patients must be 19 years of age or older.

3. ECOG PS of 0-1

4. Patients who received chemotherapy for malignancies other than pancreatic cancer are eligible, provided that chemotherapy was completed > 5 years ago and there is no evidence of the prior malignancy at the time of study entry.

5. All patients must have radiographically assessable disease

6. Patients must have an initial ANC greater than or equal to 1000/μL and platelet count greater than or equal to 100,000/μL

7. Patient must have normal serum potassium, magnesium and corrected calcium level

8. Patients must have a serum creatinine less than or equal to 2.0 mg/dL

9. Patients must have a total bilirubin <= 1.5 mg/dL (unless the patient has Gilbert disease with elevated non-conjugated (indirect) bilirubin; in such cases, the indirect bilirubin should be <= 1.0 mg/dL). If the patient has biliary obstruction, biliary decompression will be required. Either endoscopic placement of biliary stent or percutaneous transhepatic drainage are acceptable. Once biliary drainage has been established, institution of FOLFOX therapy may proceed when the total bilirubin falls to <= 5.0 mg/dL. The addition of irinotecan will be delayed until the total bilirubin is 1.5 mg/dL or lower.

10. The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.

11. No prior chemotherapy for pancreatic cancer

Exclusion Criteria:

1. Patients who cannot undergo staging laparoscopy. For example, this may include patients with a prior history of multiple abdominal operations in which laparoscopy may not be technically feasible or might be potentially harmful.

2. Patients with a contra-indication to receiving digoxin therapy, such as AV block, sick sinus syndrome, bradycardia, and hypersensitivity to digoxin or digitalis preparations.

3. Uncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that might jeopardize the ability of the patient to receive the therapy program outlined in this protocol with reasonable safety.

4. Pregnant and nursing women are excluded from this study because of the risk posed by the chemotherapy agents. Female patients of childbearing potential must have a negative urine pregnancy test before receiving the first dose of study drug

5. Patients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years.

6. Patients with known HIV infection or active hepatitis B or C infection due to concern for increased toxicity

7. Patients with an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis).

8. Patients with a recognized acquired, hereditary, or congenital immunodeficiency disease including cellular immunodeficienciess, hypogammaglobulinemia, or dysgammaglobulinemia.