Clinical trial NCT00761241: Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT
Official title: A Phase II Protocol in Borderline Resectable Pancreatic Cancer Using Gemcitabine/Docetaxel Chemotherapy and An Oxaliplatin-Based Chemoradiation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: pancreas cancer
combined modality therapy
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being conducted to find out what effects (good and bad) that a combination of treatment with chemotherapy, radiation therapy and surgery has on you and your pancreatic cancer. The chemotherapy drugs to be used: Gemcitabine, Docetaxel, Oxaliplatin, 5-FU and alpha-interferon. The goal is to decrease the size of the tumor, so that removal by surgery can be performed. Current treatments for this stage of pancreas cancer offer less than ideal results, with little opportunity for treatment with curative intent.

Detailed description: Subjects must have biopsy proven adenocarcinoma of the pancreas which is bidimensionally measurable on CT. Cancer must be considered locally advanced (not able to be treated surgically). Subjects must not have received prior treatment for pancreatic cancer. Subjects must not have received prior radiation therapy to the abdomen or pelvis (for any reason). Subjects cannot be receiving immunosuppressive therapy (e.g. prednisone, methotrexate). Eligible subjects will receive initial chemotherapy regimen to include eight cycles of Gemcitabine and Docetaxel. All subjects will be re-evaluated for surgery - if tumor has shrunk enough, subject will undergo surgery, followed by additional chemotherapy of Oxaliplatin, 5FU and Alpha-interferon and radiation therapy; once subject has recovered from side effects of the chemo/radiation therapy, they will receive a final chemotherapy regimen of four cycles of Gemcitabine and docetaxel. Subjects who are not surgical candidates after eight cycles of chemotherapy will undergo an additional four cycles of Gemcitabine and docetaxel followed by reassessment for surgery. If they are a surgical candidate, they will undergo surgery followed by chemo/radiation therapy regimen. If they are not a surgical candidate, they will undergo the chemo/radiation therapy regimen.

Subjects may be removed from the study treatment for the following reasons:

* The investigator feels the subject is not benefitting from treatment
* The subject chooses to discontinue for any reason
* The subject experiences side effects which are considered to be unacceptable
* The subject has an increase in the size of their tumor

Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the pancreas
* Tumor must be radiographically bidimensional by abdominal/pelvic CT
* Cancer must be locally advanced and not considered immediately treated by standard surgical procedure
* No prior therapy for pancreas cancer

Exclusion Criteria:

* Women who are pregnant or lactating
* Subjects who have received prior external beam radiation to the abdomen or pelvis
* Subjects receiving chronic immunosuppressive therapy (prednisone, methotrexate)

Primary outcomes:
measure: Two year overall survival
timeFrame: two years
Secondary outcomes:
measure: median disease free survival initial response rate to gemcitabine/docetaxel (tumor marker and radiographic) toxicity of overall regimen time to disease progression percentage of patients able to complete protocol to entirety
timeFrame: two years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Vincent Picozzi, MD
role: PRINCIPAL_INVESTIGATOR
References: