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Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00761241
First received: September 25, 2008
Last updated: May 25, 2010
Last verified: May 2010

September 25, 2008
May 25, 2010
September 2008
March 2010   (final data collection date for primary outcome measure)
Two year overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00761241 on ClinicalTrials.gov Archive Site
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 [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Borderline Resectable Pancreatic Cancer: Gemcitabine/Docetaxel and Oxaliplatin Based Chemo/RT
A Phase II Protocol in Borderline Resectable Pancreatic Cancer Using Gemcitabine/Docetaxel Chemotherapy and An Oxaliplatin-Based Chemoradiation.

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.

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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: Gemcitabine, Docetaxel, 5FU, Oxaliplatin
    Gemcitabine: 1000 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8cycles Docetaxel: 40 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8 cycles Gemcitabine/docetaxel will be repeated (based upon initial response) Oxaliplatin: 40 mg/m2 IV on day 1 of each week of radiation 5-FU: 175 mg/m2 continuous infusion on days 1-18 and 29-46 of radiation
  • Biological: Alpha-interferon
    Alpha-interferon: injected subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 29, 31, 33, 36, 38, 40, 43 and 46 during radiation therapy
  • Radiation: Abdominal/pelvic radiation therapy
    3-D conformal technique. The dose per fraction will be 180cGy, with a total dose of 5040 cGy in 28 fractions. Radiation therapy will be delivered on days 1-18 and days 29-46
  • Procedure: Pancreaticoduodenectomy
    Surgery performed if subject is considered candidate by protocol definition.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2010
March 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00761241
IRB07124, IST14087
No
Vincent Picozzi, MD/Principal Investigator, Virginia Mason Medical Center
Benaroya Research Institute
Sanofi
Principal Investigator: Vincent Picozzi, MD Virginia Mason Medical Center
Benaroya Research Institute
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP