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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01065870
Enrollment
64
Registered
2010-02-09
Start date
2009-12-31
Completion date
Unknown
Last updated
2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer Stage II, Pancreatic Cancer Stage III

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.

Interventions

DRUGNeoadjuvant 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.

DRUGGemcitabine, 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.

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate2 years

Secondary

MeasureTime frame
To describe the effect of neoadjuvant GTX regimen on resectability for those with arterial involvement and those with venous involvement, separately12 weeks

Countries

United States

Contacts

Primary ContactKyung Chu, RN
kc2113@columbia.edu212-305-9467
Backup ContactJessica Neufield
jn2325@columbia.edu2123051440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026