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

NCT01534637 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: IRB00000209NCI-2009-01258CCCWFU 02205
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (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.

  Over 10 weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

Treatment (antiemetic, chemotherapy, and radiation therapy)

EXPERIMENTAL

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. 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.

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

Interventions

aprepitant DRUG

Given PO

Also known as: Emend, L-754030, MK-0869, ONO-7436

Treatment (antiemetic, chemotherapy, and radiation therapy)

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (antiemetic, chemotherapy, and radiation therapy)

capecitabine DRUG

Given PO

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

Treatment (antiemetic, chemotherapy, and radiation therapy)

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Treatment (antiemetic, chemotherapy, and radiation therapy)

radiation therapy PROCEDURE

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (antiemetic, chemotherapy, and radiation therapy)

questionnaire administration OTHER

Ancillary studies

Treatment (antiemetic, chemotherapy, and radiation therapy)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (antiemetic, chemotherapy, and radiation therapy)

nausea and vomiting therapy PROCEDURE

Receive aprepitant

Also known as: antiemetic support, management of nausea and vomiting, nausea and vomiting management, therapy, nausea and vomiting, vomiting and nausea management

Treatment (antiemetic, chemotherapy, and radiation therapy)

management of therapy complications PROCEDURE

Receive aprepitant

Also known as: complications of therapy, management of

Treatment (antiemetic, chemotherapy, and radiation therapy)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Nausea; Vomiting; Pancreatic Neoplasms

Interventions

Aprepitant; Gemcitabine; Capecitabine; Fluorouracil; Radiotherapy; Radiation; Therapeutics

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Physical Phenomena

Results Point of Contact

• Title: James Lovato, MS
• Organization: Comprehensive Cancer Center of Wake Forest University

jlovato@wakehealth.edu

336-713-4172

Study Officials

• Arthur Blackstock

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 17, 2012
• Study Start: August 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2012
• Last Updated: August 15, 2018
• Results First Posted: October 30, 2012

Record last verified: 2018-07

Locations

US (1)