Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery

NCT ID: NCT00833859

Last Updated: 2017-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-03-31

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

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 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 appropriate.

Conditions

Pancreatic Neoplasms

Keywords

stereotactic radiosurgery; borderline resectable pancreatic cancer; gastrointestinal; pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy followed by Radiation Treatment

GTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS)

Group Type: EXPERIMENTAL

GTX (gemcitabine, docetaxel and capecitabine)

Intervention Type: DRUG

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

stereotactic body radiation therapy

Intervention Type: RADIATION

stereotactic body radiation therapy (SBRT) 25

Interventions

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

Intervention Type: DRUG

stereotactic body radiation therapy

stereotactic body radiation therapy (SBRT) 25

Intervention Type: RADIATION

Other Intervention Names

Gemcitabine; Taxotere®; docetaxel; Xeloda®; capecitabine; SBRT

Eligibility Criteria

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 < 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

IST 14091

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-15587

Identifier Type: -

Identifier Source: org_study_id