Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma

NCT01360593 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 08-139
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The current study seeks to further investigate the impact of up-front systemic therapy in combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic adenocarcinoma.

Conditions

Pancreatic Cancer

Keywords

Pancreas

Outcome Measures

Primary Outcomes (1)

• Local Progression-free Survival (LPFS)

  LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume. Death or development of distant disease is not regarded as an event. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, progressive disease is defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started.

  Up to 32 months

Secondary Outcomes (9)

• Objective Response Rate (ORR) (Neoadjuvant Chemotherapy)

  Up to 24 months

• Objective Response Rate (ORR) (Surgery After Chemotherapy and SBRT)

  Up to 24 months

• Overall Survival (OS)

  Up to 32 months

• Time to Progression (TTP)

  Up to 5 years

• The Functional Assessment of Cancer Therapy - General (FACT-G)

  Baseline; 2 - 4 weeks post chemotherapy; 4-6 weeks post SBRT; after surgery (up to 24 months)

Study Arms (1)

Gem, Xeloda, SBRT

OTHER

Drug: Gemcitabine; Drug: Capecitabine; Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Gemcitabine DRUG

Gemcitabine will be administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows: Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.

Also known as: Gemzar

Gem, Xeloda, SBRT

Capecitabine DRUG

Capecitabine will be taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows: Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.

Also known as: Xeloda

Gem, Xeloda, SBRT

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Fractionated SBRT will be delivered to patients that have stable disease, partial response, or complete response after chemo in the following manner: 12 Gy x 3 fractions (36 Gy total) This will be given every other day.

Also known as: CyberKnife, Trilogy, True Beam, Radiosurgery, SBRT

Gem, Xeloda, SBRT

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically proven adenocarcinoma of the pancreas
• Subjects will be staged according to the 2010 AJCC staging system with pathologic stage T1-4, N0-1 being eligible; and have a primary tumor of the pancreas (i.e., pancreatic head, neck, uncinate process, body/tail
• Tumor must be deemed to be borderline resectable or locally advanced by radiographic criteria defined by Varadhachary et al.26 Final CT confirmation of surgical staging/eligibility will be by two expert pancreatic surgeons
• Disease confined to locoregional site confirmed by FDG-PET/CT or CT and diagnostic staging laparoscopy to ensure no occult peritoneal implants
• Disease must be encompassed in a reasonable SBRT "portal" as defined by the treating radiation oncologist
• Measurable disease on imaging studies (MRI, CT, FDG-PET/CT or physical exam), including maximum diameter/dimension, must be present for assessment of response
• Karnofsky performance status \> 70 (ECOG 0-1)
• Age \> 18
• Estimated life expectancy \> 12 weeks
• Patient must have adequate renal function as defined by serum creatinine\<1.5mg/dl obtained within 28 days prior to registration
• Patient must have adequate bone marrow function as defined by absolute neutrophil count\>1500/mcl and platelets\>100,000/mcl, obtained within 28 days prior to registration
• Patient must have adequate hepatic function as defined by total bilirubin \<1.5 x IULN(institutional upper limit of normal) and either SGOT or SGPT \<2.5x IULN, obtained within 28 days prior to registration.
• Patient must be able to swallow enteral medications. Patient must not require a feeding tube. Patient must not have intractable nausea or vomiting, GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, or uncontrolled inflammatory bowel disease (Chron's, ulcerative colitis).
• Diabetes must be controlled prior to FDG-PET/CT scanning (blood glucose \<200 mg/dL)
• Ability to provide written informed consent

You may not qualify if:

• Non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas are not eligible.
• Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
• Subjects with recurrent disease
• Prior radiation therapy to the upper abdomen or liver
• Prior chemotherapy
• Subjects in their reproductive age group should use an effective method of birth control. Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study
• Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
• Concurrent serious infection
• Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ, adequately treated basal cell or squamous cell carcinoma of the skin, and treated low-risk prostate cancer.

Sponsors & Collaborators

• David A. Clump, MD, PhD: lead

Study Sites (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 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; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Barbara Stadterman, Regulatory Supervisor, MPH, CCRP
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• David A Clump, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Radiation Oncology

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 25, 2011
• Study Start: July 25, 2011
• Primary Completion: March 13, 2016
• Study Completion: October 1, 2018
• Last Updated: March 8, 2022
• Results First Posted: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)