Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery
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ClinicalTrials.gov Identifier: NCT00833859 |
Recruitment Status :
Terminated
(Abandoned - Lack of funding after only 2 patients enrolled)
First Posted : February 2, 2009
Results First Posted : May 26, 2011
Last Update Posted : October 9, 2017
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Neoplasms | Drug: GTX (gemcitabine, docetaxel and capecitabine) Radiation: stereotactic body radiation therapy | Phase 2 |
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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
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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 appropriate.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
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Experimental: Chemotherapy followed by Radiation Treatment
GTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS)
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Drug: GTX (gemcitabine, docetaxel and capecitabine)
GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14
Other Names:
Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT) 25
Other Name: SBRT |
- Number of Participants With Resectability [ Time Frame: 6 months per patient ]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.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: 6 months per patient ]Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.
- Number of Participants With Objective Response [ Time Frame: 6 months per patient ]Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.
- Number of Participants With Overall Survival [ Time Frame: 6 months per patient ]We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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%.
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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 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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833859
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Gregory Springett, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00833859 |
Other Study ID Numbers: |
MCC-15587 IST 14091 ( Other Identifier: Sanofi-Aventis US Inc. ) |
First Posted: | February 2, 2009 Key Record Dates |
Results First Posted: | May 26, 2011 |
Last Update Posted: | October 9, 2017 |
Last Verified: | December 2013 |
stereotactic radiosurgery borderline resectable pancreatic cancer gastrointestinal pancreas |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine Docetaxel Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators |