GTX-RT in Borderline Resectable Pancreatic Cancer

Stopped early · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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 participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed completely.

Key facts

Study ID

NCT01754623

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

9

Starts

2013-02-01

Expected to finish

2014-10-01

Last updated by the study team

2015-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 </= 180°
• circumferential tumor abutment with the superior mesenteric artery (SMA) over </= 180°
• Short segment encasement (360°) 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 (ULN)
• total bilirubin will allow for 2x the upper limit of the institution. Patients may have biliary stents or drains to lower total bilirubin to this range.
• 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

You may not qualify if…

• 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.
• 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 Performance Status 3-4
• Pregnant or breast-feeding 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
• Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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