Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
- Pancreatic cancer is the fourth leading cause of cancer death in the United States.
- Surgery offers the only chance at cure; however, less than 20% of patients are
considered resectable at initial presentation.
- A common reason for being classified as unresectable is loco-regional advanced disease.
- Several phase I studies of regional administration of chemotherapy have proven safe.
- The main advantage of pancreatic cancer targeted arterial perfusion of Gemcitabine is
achievement of higher local bio-available active drug levels at the tumor bed.
- The RECLAP trial is a phase I trial offering highly selective 24-hour intra-arterial
administration of Gemcitabine via a subcutaneous port for patients with unresectable
locally-advanced pancreatic cancer.
- To evaluate feasibility and toxicity of intra-arterial gemcitabine therapy (DLT).
- To establish the maximum tolerated dose (MTD)
- To evaluate response rate using RECIST, PET, MRI and CT perfusion criteria (EASL)
- To determine progression free and overall survival.
- To evaluate the conversion rate from unresectable or borderline resectable to
potentially resectable pancreatic cancer.
- To determine progression-free and overall survival.
- To analyze potential selection criteria to be used in future studies for patients who
present with marginally unresectable or unresectable locally-advanced pancreatic cancer
that might benefit from this approach.
- Unresectable locally-advanced pancreatic cancer.
- 18 years old or greater with an ECOG 0-2
- Laboratory and physical examination parameters within acceptable limits by standard of
practice guidelines prior to surgery or chemotherapy.
- No extra-pancreatic disease except regional lymph nodes.
- This is a dose escalation phase-I study.
- Patients considered unresectable due to locally-advanced pancreatic cancer will receive
selective arterial perfusion of gemcitabine over 24 hours via a subcutaneous indwelling
- Treatment will be given on Days 1 and 14. One cycle = 4 weeks for up to six cycles.
- Three to six patients will be enrolled per dose cohort.
- 18 to 36 patients in 7 cohorts will be accrued plus 6 more patients at the MTD over 36
months. Patients will be evaluated every 2 cycles (8 weeks). Upon progression patients
will be taken off study. If no PD, patients will continue up to 6 cycles.
- Chemotherapy na ve patients and patients who received previously chemotherapy including
gemcitabine will be allowed, as this mode of administration has better bioavailability,
offer potential for better biological effect and less systemic toxicity profiles.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
-To evaluate feasibility and toxicity profile and DLT (dose limiting toxicity).
Udo Rudloff, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|