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

NCT02394535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-09-02

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Eugene J Koay, MD,PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-12
Primary Completion
2022-08-31
Completion
2022-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02394535 on ClinicalTrials.gov