Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
18 Years
N/A
Both
Histologically or Cytologically Confirmed Pancreatic Ca, Unresectable or Borderline Resectable Pancreatic Ca
Trial Information
Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
Background:
- 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.
Objectives:
Primary Objective:
- To evaluate feasibility and toxicity of intra-arterial gemcitabine therapy (DLT).
- To establish the maximum tolerated dose (MTD)
Secondary Objectives:
- 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.
Eligibility:
- 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.
Design:
- 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
port.
- 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.
Inclusion Criteria
- INCLUSION CRITERIA:
- Histologically or cytologically confirmed locally advanced pancreatic adenocarcinoma
or clinical and radiographic evidence of pancreatic cancer
Note: Patients with a limited disease burden outside the pancreas, who have undergone
systemic chemotherapy for metastatic disease and have achieved a complete response on the
metastatic lesions of greater than or equal to 6 months, and have no evidence of disease
outside the pancreas at time of enrollment, are eligible.
- Disease must be evaluable
- Disease should be deemed unresectable by the MD Anderson criteria
- Patients may be chemo naive or have received prior chemotherapy (including
Gemcitabine) and/or radiation
- Greater than or equal to 18 years of age
- Must be able to understand and sign the Informed Consent Document
- Clinical performance status of ECOG less than or equal to 2
- Life expectancy of greater than three months
- Patients of both genders must be willing to practice birth control during and for
four months after receiving chemotherapy
- Hematology:
- Absolute neutrophil count greater than 1300/mm(3) without the support of
Filgrastim.
- Platelet count greater than 75,000/mm(3).
- Hemoglobin greater than 8.0 g/dl.
- Chemistry:
- Serum ALT/AST less or equal to 3 times the upper limit of normal, unless patient
carries a biliary stent. For these patients, to account for asymptomatic,
transient elevations in transaminases ('transaminitis'), serum ALT/AST may be
less than or equal to 5 tims the upper limit of normal provided all other
eligibility parameters are met.
- Serum creatinine less than or equal to 1.8 mg/dl unless the measured creatinine
clearance is greater than 60 mL/min/1.73 m(2)
- Total bilirubin less than or equal to 2 mg/dl,
- PT within 2 seconds of the upper limit of normal or INR less than or equal to
1.8
- No history of prior/other malignancies within the 2 years prior to enrollment with
the exception of basal cell carcinoma
EXCLUSION CRITERIA:
- Metastatic disease including malignant ascities
- Women of child-bearing potential who are pregnant or breastfeeding because of the
potentially dangerous effects of the chemotherapy on the fetus or infant.
- Active systemic infections, coagulation disorders or other major medical illnesses of
the cardiovascular, respiratory or immune system, myocardial infarction, heart
failure
- Childs B or C cirrhosis or with evidence of severe portal hypertension by history,
endoscopy, or radiologic studies
- Weight less than 40 kg
- Significant ascites, greater than 1000cc in the absence of peritoneal disease
- Concomitant medical problems that would place the patient at an unacceptable risk for
the procedure
- Need for concurrent chemotherapy
- Discretion of the PI
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
-To evaluate feasibility and toxicity profile and DLT (dose limiting toxicity).
Principal Investigator
Udo Rudloff, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
110099
NCT ID:
NCT01294358
Start Date:
January 2011
Completion Date:
December 2014
Related Keywords:
- Histologically or Cytologically Confirmed Pancreatic Ca
- Unresectable or Borderline Resectable Pancreatic Ca
- Pancreatic Cancer
- Regional Therapy
- Selective Arterial Infusion
- Locally Advanced Disease
- Pancreatic Neoplasms
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
