NCT02394535

Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients With Locally Advanced Pancreatic Cancer

Combining Abraxane With Capecitabine and Radiation Therapy for Consolidation of Treatment Following Induction Chemotherapy for Locally Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of nab-paclitaxel when given together with capecitabine and radiation therapy following first treatment with chemotherapy (induction therapy) in treating patients with pancreatic cancer that is not spread to tissue far away but is not operable due to abutment or encasement of blood vessels nearby (locally advanced). Drugs used in chemotherapy, such as nab-paclitaxel and capecitabine, 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, capecitabine, and radiation therapy together may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of combining nab-paclitaxel (abraxane) with capecitabine and radiation (radiation therapy) for consolidating treatment after induction chemotherapy for locally advanced pancreatic cancer. SECONDARY OBJECTIVES: I. To evaluate whether combining abraxane with capecitabine and radiation for consolidating treatment after induction chemotherapy for locally advanced pancreatic cancer increases overall survival. II. To analyze fine needle aspiration (FNA) or core needle biopsy samples for mothers against decapentaplegic homolog 4 (SMAD4) by immunocytochemistry. III. To evaluate plasma cytokines levels, circulating tumor cells before, during and after therapy. IV. To evaluate patient-reported symptoms using the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI). V. To evaluate response rate in patients treated at the maximum tolerated dose (MTD). OUTLINE: This is a dose-escalation study of nab-paclitaxel. Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29 and capecitabine orally (PO) twice daily (BID) on days 1-5 (Monday-Friday). Patients also undergo radiation therapy once daily (QD) on days 1-5 (Monday-Friday). Treatment continues for 5 1/2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4-6 weeks and then every 3 months.

Conditions

• Borderline Resectable Pancreatic Adenocarcinoma
• Locally Advanced Pancreatic Adenocarcinoma
• Pancreatic Adenocarcinoma
• Stage II Pancreatic Cancer AJCC v6 and v7
• Stage IIA Pancreatic Cancer AJCC v6 and v7
• Stage IIB Pancreatic Cancer AJCC v6 and v7
• Stage III Pancreatic Cancer AJCC v6 and v7

Interventions

Type	Name	Description
DRUG	Capecitabine	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nab-paclitaxel	Given IV
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2015-11-12
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2015-03-20
• Last updated: 2022-09-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study