NCT01065870

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2014-12-01
• First posted: 2010-02-09
• Last updated: 2014-01-29

Locations

1 site across 1 country: United States