Pancreatic Cancer
Conditions
Keywords
pancreatic cancer
Brief summary
This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.
Detailed description
The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.
Interventions
DRUGGemcitabine
gemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT. Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks.
DRUGAbraxane
Abraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT
RADIATIONRadiation Therapy
IMRT Dose escalation: 60 Gy (2 Gy/fraction)
Sponsors
Olugbenga Olowokure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven carcinoma of the pancreas that is locally advanced * ECOG performance status 0- 2 * Adequate labs * No prior abdominal radiation therapy * No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years * All disease must be encompassed within a radiotherapy portal * Not pregnant or nursing
Exclusion criteria
* Patient has metastatic disease on radiological staging * systemic therapy. * Patient has known active infection with HIV, hepatitis C or hepatitis B * Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug. * Patient is deemed to be have obvious resectable disease at presentation * Received any investigational agent within a month prior to enrollment. * Neuroendocrine tumors of the pancreas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase overall survival | 23 months | Estimated increase in median survival from 11 to 16 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of local control | baseline to average up to 24 weeks | Determine rate of local control from the date of start of treatment to the date of the time of local progression |
Countries
United States
Outcome results
None listed