Aprepitant In Preventing Nausea And Vomiting In Patients Undergoing Chemotherapy And Radiation Therapy For Pancreatic Cancer

Study Overview

Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer

This pilot clinical trial is studying how well aprepitant works in preventing nausea and vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer. Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in patients receiving chemotherapy and radiation therapy

PRIMARY OBJECTIVES: I. Discern the gastrointestinal toxicities associated with 5-FU (fluorouracil)/Gemcitabine (gemcitabine hydrochloride) chemotherapy when combined with upper abdominal radiation therapy. II. Determine if the addition of prophylactic Aprepitant/5HT-3/Dexamethasone therapy to standard chemoradiation for patients with pancreatic cancer results in less nausea and vomiting when compared to historical controls. SECONDARY OBJECTIVES: I. To determine the impact of prophylactic Aprepitant/5HT-3/Dexamethasone therapy on the impact of emesis on daily living, as measured using the MASCC Antiemesis (MAT) tool. OUTLINE: CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine orally (PO) twice daily on days 1-5. PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Extrahepatic Bile Duct Cancer
Nausea
Vomiting
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: aprepitant
DRUG: gemcitabine hydrochloride
DRUG: capecitabine
DRUG: fluorouracil
PROCEDURE: radiation therapy
OTHER: questionnaire administration
PROCEDURE: quality-of-life assessment
PROCEDURE: nausea and vomiting therapy
PROCEDURE: management of therapy complications

IRB00000209
NCI-2009-01258 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
CCCWFU 02205 (OTHER Identifier) (OTHER: Wake Forest University Health Sciences)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-02-14	Results First Submitted 2012-08-29	Last Update Submitted that met QC Criteria 2018-07-16
First Submitted that Met QC Criteria 2012-02-16	Results First Submitted that Met QC Criteria 2012-09-28	Last Update Posted (ACTUAL) 2018-08-15
First Posted (ACTUAL) 2012-02-17	Results First Posted 2012-10-30	Last Verified 2018-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (antiemetic, chemotherapy, and radiation therapy) CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.	DRUG: aprepitant Given PO DRUG: gemcitabine hydrochloride Given IV DRUG: capecitabine Given PO DRUG: fluorouracil Given IV PROCEDURE: radiation therapy Undergo radiation therapy OTHER: questionnaire administration Ancillary studies PROCEDURE: quality-of-life assessment Ancillary studies PROCEDURE: nausea and vomiting therapy Receive aprepitant PROCEDURE: management of therapy complications Receive aprepitant

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (antiemetic, chemotherapy, and radiation therapy)

CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.

DRUG: aprepitant

Given PO

DRUG: gemcitabine hydrochloride

Given IV

DRUG: capecitabine

Given PO

DRUG: fluorouracil

Given IV

PROCEDURE: radiation therapy

Undergo radiation therapy

OTHER: questionnaire administration

Ancillary studies

PROCEDURE: quality-of-life assessment

Ancillary studies

PROCEDURE: nausea and vomiting therapy

Receive aprepitant

PROCEDURE: management of therapy complications

Receive aprepitant

Primary Outcome Measures	Measure Description	Time Frame
Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation	Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses.	Over 10 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs		Week 1
Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs		Week 5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologic or cytologic diagnosis of carcinoma arising from the pancreas
Resected or unresectable pancreatic cancer, potentially resectable, or resectable (neoadjuvant) disease (stage II and III); stage IV patients with symptomatic back pain requiring palliation are also eligible at the discretion of the Principal Investigator (PI); resected patients, i.e. - "Whipple" of biliary ductal cancers are also eligible at the discretion of the PI
Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Evidence of disease; this can be measurable, evaluable, or nonmeasurable
Estimated life expectancy of at least 12 weeks
Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 X 10^9/L
Platelets >= 100 X 10^9/L
Hemoglobin >= 9 g/dL
Bilirubin =< 1.5 times upper limit of normal (ULN)
Alkaline phosphatase (AP) =< 3.0 ULN ( AP =< 5 x ULN is acceptable if liver has tumor involvement)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 ULN (AST and ALT =< 5 x ULN is acceptable if liver has tumor involvement)
Albumin >= 3.0 g/dL
Signed informed consent from patient
Male and female patients with reproductive potential must use an approved contraceptive method (e.g., intrauterine device, birth control pills, or barrier device) during and for 3 months after the study

Active infection (at the discretion of the investigator)
Neuroendocrine tumor of the pancreas
Documented brain metastasis; brain imaging in symptomatic patients is required to rule out metastases, but not required in asymptomatic patients
Pregnancy
Breast feeding
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
Use of any investigational agent within 4 weeks before enrollment into the study
Significant cardiovascular disease in the form of abnormal electrocardiogram (ECG) coupled with clinical features of recent or recurrent cardiac disease (including myocardial infarction, angina or hypertension)
Prior treatment with chemotherapy for pancreatic cancer
Clinically significant effusions (pleural or peritoneal) that cannot be drained

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)
Merck Sharp & Dohme LLC

Investigators

PRINCIPAL_INVESTIGATOR: Arthur Blackstock, Wake Forest University Health Sciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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