Phase 2
N=22
Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer
Extrahepatic Bile Duct Cancer · Nausea · Vomiting · Stage II Pancreatic Cancer · Stage III Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01534637 ↗Enrolled (actual)
22
Serious AEs
19.1%
Results posted
Oct 2012
Primary outcome: Primary: 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 — 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- aprepitant (Drug); gemcitabine hydrochloride (Drug); capecitabine (Drug); fluorouracil (Drug); radiation therapy (Procedure); questionnaire administration (Other); quality-of-life assessment (Procedure); nausea and vomiting therapy (Procedure); management of therapy complications (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
3 | — |
| SECONDARY Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs |
6 | — |
| SECONDARY Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs |
5 | — |
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
Eligibility Criteria
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 = = 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
Data sourced from ClinicalTrials.gov (NCT01534637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.