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Extrahepatic Bile Duct CancerPhase 2NCT01534637

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

A Phase 2 study testing aprepitant, gemcitabine hydrochloride and capecitabine in people with Extrahepatic Bile Duct Cancer and Nausea, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extrahepatic Bile Duct Cancer, Nausea, Vomiting
What is being tested?
aprepitant, gemcitabine hydrochloride and capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Aug 2006to Aug 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Feasibility Study to Discern the Tolerability of 5-FU/Gemcitabine Based Chemotherapy Concurrent With Upper Abdominal Radiation and the Utility of Aprepitant/5HT-3 Antagonist (EMEND) for the Prevention of ChemoRadiation-Induced Nausea and Vomiting (CRINV)

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
aprepitant, gemcitabine hydrochloride, capecitabine, fluorouracil, radiation therapy
Medical subject headings
Bile Duct Neoplasms, Nausea, Vomiting, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aprepitantDrug

    Also called Emend, L-754030, MK-0869, ONO-7436

    Given PO

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • capecitabineDrug

    Also called CAPE, Ro 09-1978/000, Xeloda

    Given PO

  • fluorouracilDrug

    Also called 5-fluorouracil, 5-Fluracil, 5-FU

    Given IV

  • radiation therapyProcedure or surgery

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo radiation therapy

  • questionnaire administrationOther

    Ancillary studies

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

  • nausea and vomiting therapyProcedure or surgery

    Also called antiemetic support, management of nausea and vomiting, nausea and vomiting management, therapy, nausea and vomiting

    Receive aprepitant

  • management of therapy complicationsProcedure or surgery

    Also called complications of therapy, management of

    Receive aprepitant

Study groups in NCT01534637
Study groupRoleWhat they receive
Treatment (antiemetic, chemotherapy, and radiation therapy)ExperimentalCHEMORADIOTHERAPY: 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. 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Over 10 weeks

Secondary outcomes (2)

  1. Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs

    Measured: Week 1

  2. Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs

    Measured: Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2012 (estimated)
  2. Study startAug 2006
  3. Primary completionDec 2009
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01534637
Sponsor's protocol ID
IRB00000209
Other IDs
NCI-2009-01258, CCCWFU 02205
Status last verified
Jul 2018
First submitted
14 Feb 2012
Last updated
15 Aug 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aprepitant, gemcitabine hydrochloride and capecitabine in people with Extrahepatic Bile Duct Cancer and Nausea, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Over 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01534637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.

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