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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Columbia University
Sponsor:
Information provided by (Responsible Party):
William Sherman, Columbia University
ClinicalTrials.gov Identifier:
NCT01065870
First received: February 8, 2010
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: December 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065870

Contacts
Contact: Kyung Chu, RN 212-305-9467 kc2113@columbia.edu
Contact: Jessica Neufield 2123051440 jn2325@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kyung Chu, RN    212-305-9467    kc2113@columbia.edu   
Contact: Jessica Neufield    2123051440    jn2325@columbia.edu   
Principal Investigator: William Sherman, MD         
Sub-Investigator: John Allendorf, MD         
Sub-Investigator: John Chabot, MD         
Sub-Investigator: Beth Schrope, MD         
Sub-Investigator: Kyung Chu, NP         
Sub-Investigator: Robert Fine, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: William Sherman, MD Columbia University
  More Information

No publications provided

Responsible Party: William Sherman, Associate Professor of Clinical Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01065870     History of Changes
Other Study ID Numbers: AAAD6491
Study First Received: February 8, 2010
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Capecitabine
Docetaxel
Fluorouracil
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014