Status:
TERMINATED
Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Sanofi
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tu...
Detailed Description
* Cycle 1 and 2: * Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m\^2 intravenous piggy back (IVPB) over 30 min * Days 4, 11 and 25, 32 ....docetaxel 30 mg/m\^2 IVPB over 1 hour * Days 1-14 and ...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as:
- circumferential tumor abutment with the superior mesenteric vein (SMV) or portal vein (PV) or SMV/PV confluence over \< 180o.
- circumferential tumor abutment with the superior mesenteric artery (SMA) over \< 180o.
- Short segment encasement (360o) of the PV or SMV that is amenable to partial vein resection and reconstruction.
- encasement of the gastroduodenal artery up to the origin of the hepatic artery
- Patients must have measurable disease.
- No previous chemotherapy or radiation to the pancreas.
- Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%.
- Patients must have normal organ and marrow function as defined below:
- leukocytes \>3,000/μL
- absolute neutrophil count \>1,000/μL
- platelets \>100,000/μL
- creatinine within normal institutional limits - OR - creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- total bilirubin \< institutional upper limit of normal (ULN). Patients may have biliary stents or drains to lower total bilirubin to this range.
- Aspartate Aminotransferase (AST) serum glutamic oxaloacetic transaminase(SGOT) / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase(SGPT) AST and ALT may be up to 2.5 times ULN if alkaline phosphatase \< ULN; or alkaline phosphatase may be up to 4 times ULN if AST and ALT are \< ULN.
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential). Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients with metastatic disease are ineligible. Patients who have had prior chemotherapy for pancreatic adenocarcinoma.
- Patients who have received prior radiation to an abdominal site are not eligible.
- Prior malignancy in the last 3 years, except basal cell carcinoma, squamous cell or in-situ cervical cancer.
- Patients with peripheral neuropathy \> grade 2.
- Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel), other drugs formulated with polysorbate 80, gemcitabine, or capecitabine.
- Patients may not be receiving any other investigational agents.
- ECOG PS 3-4
- Pregnant women are excluded from this study because gemcitabine, capecitabine, and docetaxel are Class D agents with the potential for teratogenic or abortifacient effects.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- creatinine clearance \< 30 ml/min (Cockcroft-Gault method).
- Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00833859
Start Date
March 1 2009
End Date
March 1 2010
Last Update
October 9 2017
Active Locations (1)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612