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

Wake Forest University (WFU)

Status and phase

Completed

Phase 2

Conditions

Vomiting

Stage III Pancreatic Cancer

Nausea

Extrahepatic Bile Duct Cancer

Stage IV Pancreatic Cancer

Stage II Pancreatic Cancer

Treatments

Other: questionnaire administration

Procedure: management of therapy complications

Procedure: radiation therapy

Drug: fluorouracil

Procedure: nausea and vomiting therapy

Drug: gemcitabine hydrochloride

Procedure: quality-of-life assessment

Drug: capecitabine

Drug: aprepitant

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT01534637

IRB00000209

CCCWFU 02205 (Other Identifier)

NCI-2009-01258 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Treatment (antiemetic, chemotherapy, and radiation therapy)

Experimental group

Description:

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.

Treatment: