Recruiting

Phase 2

Phase 3

GTX with ChemoradiationNeoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)

Sponsor:

Columbia University

Code:

NCT01065870

Conditions

Pancreatic Cancer Stage II

Pancreatic Cancer Stage III

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neoadjuvant gemcitabine, capecitabine, and docetaxel

Gemcitabine, capecitabine, docetaxel followed by radiotherapy

Study Details

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.

Conditions

Pancreatic Cancer Stage II

Pancreatic Cancer Stage III

Study ID

NCT01065870

Start date

Dec, 2009

Status verified date

Jan, 2014

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I

Patients with only venous involvement Treated with 6 cycles og GTX and then surgery

experimental: Group II

Patients with arterial involvement and may have venous involvement with tumor treated with 6 cycles of GTX, thenb GX/RT and then surgery

Interventions

Neoadjuvant gemcitabine, capecitabine, and docetaxel

Gemcitabine, capecitabine, docetaxel followed by radiotherapy

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.

Primary outcome measure

To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Kyung Chu, RN

212-305-9467 kc2113@columbia.edu

Jessica Neufield

2123051440 jn2325@columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Kyung Chu, RN

212-305-9467 kc2113@columbia.edu

Jessica Neufield

2123051440 jn2325@columbia.edu

Principal Investigator:

William Sherman, MD

More Information

Sponsor

Columbia University

Last update posted

Jan 29, 2014

Last verified

Jan, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2014-01-29.