Clinical trial · Interventional
Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer
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)
NCT01534637CI-TRIAL-00034377completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Nausea | — | UNRESOLVED | — |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aprepitant | Drug | — | UNRESOLVED |
| capecitabine | Drug | Capecitabine | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| management of therapy complications | Procedure | — | UNRESOLVED |
| nausea and vomiting therapy | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (antiemetic, chemotherapy, and radiation therapy)
- 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.
- interventionNames
- 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
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.