Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Summary

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
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 19 years and 125 years
Gender
Both males and females

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 comb...

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.

Tracking Information

NCT #
NCT02394535
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sunil Krishnan M.D. Anderson Cancer Center