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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Given PO
Correlative studies
Given IV
Ancillary studies
Undergo radiation therapy
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson in Katy
Houston, Texas, United States
MD Anderson Cancer Center - League City
League City, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
MD Anderson in The Woodlands
The Woodlands, Texas, United States
Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with at most 1 instance of dose limiting toxicity (DLT) according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Descriptive statistics will be used to summarize will be used to summarize patient demographic and clinical characteristics as well as the incidence of DLTs at each dose level.
Time frame: 4-6 weeks
Overall survival
The probabilities of overall survival will be estimated using the method of Kaplan and Meier.
Time frame: Up to 4 years
Response rate
The response rate for patients treated at the maximum tolerated dose will be estimated, along with the exact 95% confidence interval.
Time frame: Up to 4 years
Changes in MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI)
Descriptive statistics will be used to summarize patients' MDASI data. Paired t-test or Wilcoxon sign rank test will be used to assess the change of MDASI from baseline.
Time frame: Baseline to up to 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.