Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The PUMP-IT study is designed to prove the feasibility of HAIP chemotherapy with concomitant standard systemic chemotherapy (FOLFOX and FOLFIRI) in the Netherlands. This study will include patients with both unresectable CRLM and resectable CRLM with an indication for upfront systemic therapy (further referred to as potentially resectable CRLM), without extrahepatic metastases. The study will be performed in two tertiary referral centers in the Netherlands.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Erasmus Medical Center
• Treatments: Floxuridine

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• ECOG performance status 0 or 1.

• Life expectancy of at least 12 weeks.

• Histologically confirmed CRC.

• Indication for first or second line systemic therapy, confirmed in a multidisciplinary meeting.

• Potentially resectable (i.e. unresectable and upfront resectable CRLM with indication for neoadjuvant systemic therapy), confirmed in a multidisciplinary meeting and radio-logically on (PET) CT thorax/abdomen and/or MRI obtained ≤ 4 weeks prior to regis-tration.

• Positioning of a catheter for HAIP chemotherapy is technically feasible confirmed in the multidisciplinary liver meeting based on imaging. The default site for the catheter insertion is the gastroduodenal artery (GDA). Accessory or aberrant hepatic arteries are no contra-indication for catheter implantation. The GDA should have at least one branch to the liver, accessory or aberrant hepatic arteries should be ligated to allow for cross perfusion to the entire liver through intrahepatic shunts.

• Indication and eligibility for abdominal surgery confirmed in a multidisciplinary meeting, e.g. primary tumour resection, stoma revision/reversal and diagnostic surgery.

• In case of primary tumour in situ: tumour should be (potentially) resectable, confirmed in a multidisciplinary meeting.

• Adequate bone marrow, liver and renal function as assessed by the following labora-tory requirements to be conducted within 15 days prior to inclusion.

• Hb ≥ 5.5 mmol/L

• Absolute neutrophil count (ANC) ≥1.5 * 109/L

• Platelets ≥100 * 109/L

• Total bilirubin < 1.5 mg/dL

• ASAT ≤ 5 * times the upper limit of normal (ULN)

• ALAT ≤ 5 * ULN

• Alkaline phosphatase ≤ 5 * ULN

• (estimated) glomerular filtration rate (eGFR) > 45 ml/min.

• Before patient registration, written informed consent must be given and signed according to ICH-GCP, and national/local regulations.

Exclusion Criteria:

• Extrahepatic metastases. Confirmed with CT thorax/abdomen obtained ≤ 4 weeks prior to registration. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.

• Prior hepatic radiation, resection (other than biopsy), or ablation.

• Concurrent malignancies that interfere with the planned study treatment or the prognosis of CRLM.

• Participation in other clinical trials interfering with the study treatment as judged by the treating physician.

• Dihydropyrimidine dehydrogenasedeficiency (DPD deficiency).

• Pregnant or lactating women.

• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

• Organ allografts requiring immunosuppressive therapy.

• Serious, non-healing wound, ulcer, or bone fracture.

• Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equiv-alent excluding inhaled steroids).

• Serious infections (uncontrolled or requiring treatment).

• History of psychiatric disability judged by the investigator to potentially hamper compliance with the study protocol and follow-up schedule.

• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.