Clinical trial NCT01065870: Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pancreatic Cancer Stage II
Pancreatic Cancer Stage III
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate
timeFrame: 2 years
Secondary outcomes:
measure: To describe the effect of neoadjuvant GTX regimen on resectability for those with arterial involvement and those with venous involvement, separately
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: William Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.