Phase 1
N=4
Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
Histologically or Cytologically Confirmed Pancreatic Ca · Unresectable or Borderline Resectable Pancreatic Ca
Bottom Line
View on ClinicalTrials.gov: NCT01294358 ↗Enrolled (actual)
4
Serious AEs
23.5%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants With Dose Limiting Toxicity (DLT ) — 0; 1; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicity (DLT ) |
0; 1; 0; 0; 0 | — |
| PRIMARY MTD (Maximum Tolerated Dose) |
115 | — |
| SECONDARY Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Response Rate Using Positron Emission Tomography (PET) |
— | — |
| SECONDARY Response Rate Using Magnetic Resonance Imaging (MRI) |
— | — |
| SECONDARY Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Median Time to Progression |
2 | — |
| SECONDARY Median Overall Survival (OS) |
NA; 9; 9; 15; NA | — |
| SECONDARY Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer |
0; 0; 0; 1; 1 | — |
| SECONDARY Number of Potential Selection Criteria to Be Used in Future Studies for Patients With Marginally Unresectable Or Unresectable Locally-Advanced Pancreatic Cancer |
— | — |
| SECONDARY Number of Participants With Serious and Non-Serious Adverse Events |
4; 5; 3; 2; 1 | — |
Summary
Background:
- Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink some of the tumor, but even with chemotherapy only about 25 percent of patients will live for 1 year following diagnosis. Several preliminary studies have shown that it is safe to give chemotherapy directly into the pancreas in the area of the tumor, and that giving gemcitabine over a longer period increases the amount of drug that is available to the tumor. Researchers are interested in studying whether giving the approved pancreatic cancer chemotherapy drug gemcitabine directly into the pancreas in the area of the cancer and at a slow rate of infusion is a safe and effective treatment.
Objectives:
- To test the safety and effectiveness of administering gemcitabine directly to a pancreatic tumor at a slow rate of infusion.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that is currently too large to be removed surgically but has not yet spread to other organs.
Design:
* Participants will be screened with a full medical history and physical examination, blood and urine tests, and imaging studies.
* Participants will undergo pancreatic angiography and embolization, during which a catheter will be threaded into the blood vessels near the pancreas and a contrast dye will be used to show the blood vessels supplying the tumor. These blood vessels will then be surgically closed off.
* After the embolization, gemcitabine will be given as an infusion into the area around the tumor over 24 hours.
* Participants will return to the clinical center every 2 weeks after the first infusion for additional infusions of gemcitabine, using the same procedures as above. Participants will be monitored with frequent blood tests and imaging studies.
* Two weeks after the fourth treatment (course 1), participants will have more imaging studies, a physical examination, and blood tests. If the tumor is shrinking, participants will have two more courses of treatment (eight more infusions of gemcitabine).
* Participants will have followup visits every 3 months for 2 years following the last treatment and then every 6 months.
Eligibility 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 Eastern Cooperative Oncology Group (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 alanine aminotransferase (ALT)/aspartate aminotransferase (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 times 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,
- Prothrombin time (PT) within 2 seconds of the upper limit of normal or International Normalized Ratio (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 ascites
- 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 principal investigator (PI)
Data sourced from ClinicalTrials.gov (NCT01294358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.