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

NCT00833859 | Terminated Phase 2 Results DMC

• 2 other identifiers: MCC-15587IST 14091
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms

Keywords

stereotactic radiosurgery; borderline resectable pancreatic cancer; gastrointestinal; pancreas

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Resectability

  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.

  6 months per patient

Secondary Outcomes (3)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).

  6 months per patient

• Number of Participants With Objective Response

  6 months per patient

• Number of Participants With Overall Survival

  6 months per patient

Study Arms (1)

Chemotherapy followed by Radiation Treatment

EXPERIMENTAL

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

Drug: GTX (gemcitabine, docetaxel and capecitabine); Radiation: stereotactic body radiation therapy

Interventions

GTX (gemcitabine, docetaxel and capecitabine) 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

Also known as: Gemcitabine, Taxotere®, docetaxel, Xeloda®, capecitabine

Chemotherapy followed by Radiation Treatment

stereotactic body radiation therapy RADIATION

stereotactic body radiation therapy (SBRT) 25

Also known as: SBRT

Chemotherapy followed by Radiation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \< 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.

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.
• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Sanofi: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Docetaxel; Capecitabine; Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Early termination of study due to termination of funding. The study was closed to accrual on 12/17/09 and final closed on 3/12/10. The sample size goal of 33 evaluable participants could not be met.

Results Point of Contact

• Title: Gregory Springett, M.D., Ph.D., via Moffitt Cancer Center
• Organization: H. Lee Moffitt Cancer Center and Research Institute

gregory.springett@moffitt.org

813-745-6898

Study Officials

• Gregory Springett, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 9, 2017
• Results First Posted: May 26, 2011

Record last verified: 2013-12

Locations

US (1)