Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 10/3/2018 |
| Start Date: | January 26, 2011 |
| End Date: | July 23, 2014 |
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.
- 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.
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 Regional Chemotherapy in Locally Advanced Pancreatic Cancer (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 (dose
limiting toxicity (DLT)).
- To establish the maximum tolerated dose (MTD)
Secondary Objectives:
- To evaluate response rate using Response Evaluation Criteria in Solid Tumors (RECIST),
positron emission tomography (PET), magnetic resonance imaging (MRI) and computed
tomography (CT) perfusion criteria (European Association for the Study of the Liver
(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 Eastern Cooperative Oncology Group (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 maximum
tolerated dose (MTD over 36 months. Patients will be evaluated every 2 cycles (8 weeks).
Upon progression patients will be taken off study. If no progressive disease (PD),
patients will continue up to 6 cycles.
- Chemotherapy na(SqrRoot) 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.
- 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 Regional Chemotherapy in Locally Advanced Pancreatic Cancer (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 (dose
limiting toxicity (DLT)).
- To establish the maximum tolerated dose (MTD)
Secondary Objectives:
- To evaluate response rate using Response Evaluation Criteria in Solid Tumors (RECIST),
positron emission tomography (PET), magnetic resonance imaging (MRI) and computed
tomography (CT) perfusion criteria (European Association for the Study of the Liver
(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 Eastern Cooperative Oncology Group (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 maximum
tolerated dose (MTD over 36 months. Patients will be evaluated every 2 cycles (8 weeks).
Upon progression patients will be taken off study. If no progressive disease (PD),
patients will continue up to 6 cycles.
- Chemotherapy na(SqrRoot) 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:
- 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)
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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