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

NCT02394535 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2014-0469NCI-2015-00516
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  4-6 weeks

Secondary Outcomes (3)

• Overall survival

  Up to 4 years

• Response rate

  Up to 4 years

• Changes in MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI)

  Baseline to up to 4 years

Study Arms (1)

Treatment (chemotherapy, radiation therapy)

EXPERIMENTAL

Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, 15, 22, and 29 and capecitabine PO BID on days 1-5 (Monday-Friday). Patients also undergo radiation therapy QD on days 1-5 (Monday-Friday). Treatment continues for 51/2 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Capecitabine; Other: Laboratory Biomarker Analysis; Drug: Nab-paclitaxel; Other: Questionnaire Administration; Radiation: Radiation Therapy

Interventions

Capecitabine DRUG

Given PO

Also known as: Ro 09-1978/000, Xeloda

Treatment (chemotherapy, radiation therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (chemotherapy, radiation therapy)

Nab-paclitaxel DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel

Treatment (chemotherapy, radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (chemotherapy, radiation therapy)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Treatment (chemotherapy, radiation therapy)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Cytologic or histologic proof of adenocarcinoma of the pancreas; patients can have tumor which is locally advanced or borderline resectable; unequivocal metastases and islet cell tumors are not eligible
• All patients must be staged with a physical exam, computed tomography (CT) of the chest and contrast-enhanced helical thin-cut abdominal CT; unresectability is defined by CT criteria:
• Evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or
• Evidence on either CT or angiogram of occlusion of the SM vein or SM/portal vein confluence
• Patients must have received prior induction chemotherapy for at least 2 months and up to 8 months; at least three weeks should have elapsed after the last chemotherapy
• Platelets \> 100,000 cells/mm\^3
• Hemoglobin \> 9.0 g/dL
• Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
• Bilirubin =\< 1.5 mg/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x upper limit of normal
• Alkaline phosphatase \< 2.5 x upper limit of normal
• Blood urea nitrogen (BUN) \< 30 mg/dL
• Creatinine =\< 1.5 mg/dL or creatinine clearance \> 30 ml/min (estimated as calculated with Cockcroft-Gault equation)
• Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary

You may not qualify if:

• Prior abdominal radiotherapy
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study
• Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a taxane therapy
• Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil
• Prior history of cancer within the last three years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix; patients with previous malignancies but without evidence of disease for 3 years will be allowed to enter the trial
• Pregnant or lactating women; women of childbearing potential with either a positive or no pregnancy test at baseline; women/men of childbearing potential not using a reliable contraceptive method (oral contraceptive, other hormonal contraceptive, intrauterine device, diaphragm or condom); (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential); patients must agree to continue contraception for 30 days from the date of the last study drug administration
• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to swallow
• Known, existing uncontrolled coagulopathy, international normalized ratio (INR) \> 1.5
• Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine; low dose (1 mg) Coumadin is allowed; intravenous and low-molecular weight heparin are permitted
• Patients taking sorivudine or brivudine must be off of these drugs for 4 weeks prior to starting capecitabine; patients taking cimetidine must have this drug discontinued; ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary; if patient is currently receiving allopurinol, must discuss with principal investigator (PI) to see of another agent may substitute for it
• Inability to comply with study and/or follow-up procedures
• History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson in Katy

Houston, Texas, 77094, United States

Location

MD Anderson Cancer Center - League City

League City, Texas, 77573, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

MD Anderson in The Woodlands

The Woodlands, Texas, 77384, United States

Location

Related Publications (1)

• Koay EJ, Zaid M, Aliru M, Bagereka P, Van Wieren A, Rodriguez MJ, Jacobson G, Wolff RA, Overman M, Varadhachary G, Pant S, Wang H, Tzeng CW, Ikoma N, Kim M, Lee JE, Katz MH, Tamm E, Bhosale P, Taniguchi CM, Holliday EB, Smith GL, Ludmir EB, Minsky BD, Crane CH, Koong AC, Das P, Wang X, Javle M, Krishnan S. Nab-Paclitaxel, Capecitabine, and Radiation Therapy After Induction Chemotherapy in Treating Patients With Locally Advanced and Borderline Resectable Pancreatic Cancer: Phase 1 Trial and Imaging-based Biomarker Validation. Int J Radiat Oncol Biol Phys. 2022 Nov 1;114(3):444-453. doi: 10.1016/j.ijrobp.2022.06.089. Epub 2022 Jul 18.

  PMID: 35863672 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Capecitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes; Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Therapeutics; Physical Phenomena

Study Officials

• Eugene J Koay, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: November 12, 2015
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

US (5)