Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Fox Chase Cancer Center
Study ID
NCT00761345
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Pancreatic Cancer
  • Pancreatic Carcinoma Non-resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gemcitabine — DRUG
    gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.
  • Erlotinib — DRUG
    Erlotinib 100mg or 150mg daily of each 21 day cycle
  • low dose fractionated radiotherapy — RADIATION
    low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle

Study Details

People with pancreatic cancer usually have a large amount of the cancer in the area of the pancreas and around it when they are diagnosed with it. Or their cancer has spread (metastasized)outside that area of the abdomen and is not able to be surgically removed (resected). For patients with metastatic disease, one standard treatment is the combination of gemcitabine and erlotinib. This combination has shown slightly longer survival compared to getting gemcitabine alone. For patients with localized but unresectable disease, the standard treatment remains controversial. Early studies showed that chemotherapy and radiation together was better than either one used alone. The greatest benefit of external beam radiotherapy may be after a period of full-dose chemotherapy alone, to help the rapid spread. A problem of beginning treatment with standard radiotherapy is that the doses of chemotherapy usually have to be reduced sometimes by half. Studies have already shown that low dose radiotherapy (LDRT)is safe. This study will evaluate the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer. Patients will be enrolled in groups of 3 to 6 each with a slightly higher dose of LDRT and erlotinib. For patients with locally advanced disease, this protocol also may help because most patients develop and die from spread to the liver and abdominal cavity.

Key Dates

First listed
Sep 29, 2008
Start date
Sep 30, 2008
Status verified
Jan 2017
Primary completion
Jul 31, 2014
Completion
Feb 28, 2015

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: radiotherapy and chemotherapy
    gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle

Primary Outcome Measure

To Determine the Dose Limiting Toxicities [ Time Frame: weekly physician and nurse assessment and in between as needed until 30 days after treatment termination ]

Locations (3)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstitueDetroitMichigan48201-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Reading Medical CenterWest ReadingPennsylvania19611-

Find similar trials in Detroit, MI

By research site
Karmanos Cancer Institue· Detroit, MIFox Chase Cancer Center· Philadelphia, PAReading Medical Center· West Reading, PA

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