NCT02427841

Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Phase 2 Study of Preoperative Chemotherapy With Abraxane and Gemcitabine Followed by Chemoradiation for Borderline Resectable or Node-Positive Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride followed by radiation therapy before surgery work in treating patients with pancreatic cancer that can be removed by surgery. Chemotherapy drugs, such as nab-paclitaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel, gemcitabine hydrochloride, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

PRIMARY OBJECTIVE: I. To determine the R0 (complete resection) resection rate for subjects with borderline resectable or lymph node positive pancreatic adenocarcinoma treated with a multimodality neoadjuvant therapy of preoperative gemcitabine (gemcitabine hydrochloride) and ABRAXANE (nab-paclitaxel) followed by 5-fluorouracil (fluorouracil) based image-guided intensity-modulated radiation therapy (IG-IMRT) chemoradiotherapy. SECONDARY OBJECTIVES: I. To determine 1-year relapse-free survival rate with the investigational protocol. II. To determine 1-year and 2-year overall survival rates. III. To assess response rate by imaging (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and pathologic analysis. IV. To assess the toxicity and safety according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria. OUTLINE: PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 1 year.

Conditions

• Pancreatic Adenocarcinoma
• Resectable Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	Fluorouracil	Given IV
DRUG	Gemcitabine	Given IV
RADIATION	Image Guided Radiation Therapy	Undergo IG-IMRT
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IG-IMRT
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nab-paclitaxel	Given IV
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2016-01-21
• Primary completion: 2019-11-12
• Completion: 2022-12-12
• First posted: 2015-04-28
• Last updated: 2023-09-06
• Results posted: 2021-01-14

Locations

1 site across 1 country: United States