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

NCT ID: NCT01065870

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

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

Group Type: EXPERIMENTAL

Neoadjuvant gemcitabine, capecitabine, and docetaxel

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Gemcitabine, capecitabine, docetaxel followed by radiotherapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Gemzar; Xeloda; Taxotere; Gemzar; Taxotere; Xeloda

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

William Sherman

Associate Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kyung Chu, RN

Role: CONTACT

kc2113@columbia.edu

212-305-9467

Jessica Neufield

Role: CONTACT

jn2325@columbia.edu

2123051440

Facility Contacts

Kyung Chu, RN

Role: primary

kc2113@columbia.edu

212-305-9467

Jessica Neufield

Role: backup

jn2325@columbia.edu

2123051440

References

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.

Reference Type: DERIVED

PMID: 25492104 (View on PubMed)

Other Identifiers

AAAD6491

Identifier Type: -

Identifier Source: org_study_id