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

Primary Purpose

Pancreatic Cancer Stage II, Pancreatic Cancer Stage III

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Neoadjuvant gemcitabine, capecitabine, and docetaxel

Gemcitabine, capecitabine, docetaxel followed by radiotherapy

About this trial

This is an interventional treatment trial for Pancreatic Cancer Stage II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Columbia University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group I

Group II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01065870

First Posted

February 8, 2010

Last Updated

January 27, 2014

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT01065870

Brief Title

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer Stage II, Pancreatic Cancer Stage III

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Description

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

Arm Title

Group II

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Neoadjuvant gemcitabine, capecitabine, and docetaxel

Other Intervention Name(s)

Gemzar, Xeloda, Taxotere

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine, capecitabine, docetaxel followed by radiotherapy

Other Intervention Name(s)

Gemzar, Taxotere, Xeloda

Intervention Description

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 Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kyung Chu, RN

Phone

212-305-9467

kc2113@columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Neufield

Phone

2123051440

jn2325@columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Sherman, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kyung Chu, RN

Phone

212-305-9467

kc2113@columbia.edu

First Name & Middle Initial & Last Name & Degree

Jessica Neufield

Phone

2123051440

jn2325@columbia.edu

First Name & Middle Initial & Last Name & Degree

William Sherman, MD

First Name & Middle Initial & Last Name & Degree

John Allendorf, MD

First Name & Middle Initial & Last Name & Degree

John Chabot, MD

First Name & Middle Initial & Last Name & Degree

Beth Schrope, MD

First Name & Middle Initial & Last Name & Degree

Kyung Chu, NP

First Name & Middle Initial & Last Name & Degree

Robert Fine, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

25492104

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.

Results Reference

derived

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

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