Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)
Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma
1 other identifier
interventional
64
1 country
1
Brief Summary
This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedJanuary 29, 2014
January 1, 2014
5 years
February 8, 2010
January 27, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate
2 years
Secondary Outcomes (1)
To describe the effect of neoadjuvant GTX regimen on resectability for those with arterial involvement and those with venous involvement, separately
12 weeks
Study Arms (2)
Group I
EXPERIMENTALPatients with only venous involvement Treated with 6 cycles og GTX and then surgery
Group II
EXPERIMENTALPatients with arterial involvement and may have venous involvement with tumor treated with 6 cycles of GTX, thenb GX/RT and then surgery
Interventions
6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off. Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner. Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment.
6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off. Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner. Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment. Radiotherapy should start 2 to 3 weeks after last planned dose of GTX. Gemcitabine at 750mg/M2 days 5, 12, 26, 33 along with capecitabine 1000 mg bid for 5 days darbepoetin 200ug, every 2 weeks if the hemoglobin is less than 10.5 gms/dl while undergoing radiotherapy. Pegfiligastrim 6mg at the end of week 2 if the WBC count is less than 2500 cells/cu mm.
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16 mutations.)
- Locally advanced disease determined by Endoscopic ultrasound, CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
- No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
- Unresectable tumor. (this reflects those patients whose tumors abut, invade or surround a major vessel, either venous or arterial or both)
- No prior chemotherapy or radiation therapy.
- Ineligible for other high priority national or institutional studies.
- Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant, non-menopausal females.
- Must not have other underlying medical conditions that would make them ineligible for surgery, radiation therapy, or chemotherapy.
- Complete Blood Count and Complete Metabolic Profile:
- Absolute Neutrophil Count \> 1,500 μl White Blood Count \> 3,000/μl Platelet count \> 100,000/μl BUN \< 1.5 x normal Creatinine \< 1.5 normal Hemoglobin \> 8.0 g/dl Serum Albumin \> 3 mg/dl Total Bilirubin \< 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase \< 2.5 x ULN
- Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the nature of this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (1)
Sherman WH, Chu K, Chabot J, Allendorf J, Schrope BA, Hecht E, Jin B, Leung D, Remotti H, Addeo G, Postolov I, Tsai W, Fine RL. Neoadjuvant gemcitabine, docetaxel, and capecitabine followed by gemcitabine and capecitabine/radiation therapy and surgery in locally advanced, unresectable pancreatic adenocarcinoma. Cancer. 2015 Mar 1;121(5):673-80. doi: 10.1002/cncr.29112. Epub 2014 Dec 9.
PMID: 25492104DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Sherman, MD
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Clinical Medicine
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 9, 2010
Study Start
December 1, 2009
Primary Completion
December 1, 2014
Last Updated
January 29, 2014
Record last verified: 2014-01