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

Sponsor

Columbia University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01065870

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Stage II Pancreatic Cancer Stage III	Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel Drug: Gemcitabine, capecitabine, docetaxel followed by radiotherapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I Patients with only venous involvement Treated with 6 cycles og GTX and then surgery	Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel 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. Other Names: Gemzar Xeloda Taxotere
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	Drug: 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. Other Names: Gemzar Taxotere Xeloda

Arm

Intervention/Treatment

Experimental: Group I

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

Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel

Other Names:

Gemzar

Xeloda

Taxotere

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

Drug: 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.

Other Names:

Gemzar

Taxotere

Xeloda

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

To describe the effect of neoadjuvant GTX regimen on resectability for those with arterial involvement and those with venous involvement, separately [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator: William Sherman, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

William Sherman, Associate Professor of Clinical Medicine, Columbia University

ClinicalTrials.gov Identifier:

NCT01065870

Other Study ID Numbers:

AAAD6491

First Posted:

Feb 9, 2010

Last Update Posted:

Jan 29, 2014

Last Verified:

Jan 1, 2014

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 29, 2014