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A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Neoplasms

Thank you

Trial Information

A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer

- 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 22-35 ....capecitabine 750 mg/m^2 oral twice daily

- Each cycle is 21 days long

- SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume

- Cycle 3 and 4:

- Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m^2 IVPB over 30 min

- Days 54, 61 and 75, 82 ....docetaxel 30 mg/m^2 IVPB over 1 hour

- Days 51-64 ....capecitabine 750 mg/m^2 oral twice daily

- Each cycle is 21 days long

- Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or
central pancreatectomy with or without vein resection and reconstruction as

Inclusion Criteria:

- 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 <

- 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

Exclusion Criteria:

- 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

- 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

- creatinine clearance < 30 ml/min (Cockcroft-Gault method).

- Patients must not have any comorbid inflammatory conditions of the bowel such as
Crohn's Disease.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Resectability

Outcome Description:

The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.

Outcome Time Frame:

6 months per patient

Safety Issue:


Principal Investigator

Gregory Springett, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2009

Completion Date:

March 2010

Related Keywords:

  • Pancreatic Neoplasms
  • stereotactic radiosurgery
  • borderline resectable pancreatic cancer
  • gastrointestinal
  • pancreas
  • Neoplasms
  • Pancreatic Neoplasms



H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612