Clinical trial · Interventional
Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy
A Phase II Clinical Trial Investigating the Efficacy of Single-Dose Fosaprepitant for the Prevention of Cisplatin-Induced Nausea and Vomiting (CINV) in Patients With Head & Neck Cancer Undergoing Concurrent Chemotherapy and Radiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study stopped due to lack of efficacy in first 6 patients
Summary
Brief summary (as posted)
RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck cancer undergoing chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused by cisplatin in patients with stage III or stage IV head and neck cancer undergoing chemotherapy and radiation therapy.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea and Vomiting | — | UNRESOLVED | — |
| Stage III Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Squamous Cell Carcinoma of the Larynx | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Stage III Squamous Cell Carcinoma of the Nasopharynx | — | UNRESOLVED | — |
| Stage III Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| Emesis Diary | Behavioral | — | UNRESOLVED |
| fosaprepitant dimeglumine | Drug | — | UNRESOLVED |
| Functional Living Index-Emesis Questionnaire | Other | — | UNRESOLVED |
| palonosetron hydrochloride | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients also undergo radiotherapy once daily 5 days a week for up to 7 weeks. Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients then receive oral dexamethasone on days 2-4. Patients with no emesis or requirement for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin. Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.
- interventionNames
- Drug: fosaprepitant dimeglumine
- Drug: cisplatin
- Drug: palonosetron hydrochloride
- Drug: dexamethasone
- Other: Functional Living Index-Emesis Questionnaire
- Behavioral: Emesis Diary
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically or pathologically documented squamous cell carcinoma of the oral cavity, oropharynx, larynx, hypopharynx, or nasopharynx * Stage III or IV disease according to the AJCC Cancer Staging Handbook Sixth Edition * Planned definitive or adjuvant radiation with concurrent cisplatin (100 mg/m2 every 3 weeks for three cycles) * ECOG Performance Status of 0-2 * Adequate Organ Function (Hepatic: bilirubin =\< 1.5 x ULN; AST and ALT =\< 3 x ULN; Renal: calculated creatinine clearance \>= 55ml/min (using the Cockcroft-Gault Formula); Bone Marrow: platelet count \>= 100 x 10\^9/L; absolute neutrophil count \>= 1.25 x 10\^9/L) * Signed Informed Consent * Male and female patients with reproductive potential must use an acceptable contraceptive method (with double barrier protection for pre-menopausal women) * Predicted life expectancy \> 12 weeks * Willingness to complete patient diary and questionnaires Exclusion Criteria: * Inability or unwillingness to comply with radiotherapy or chemotherapy * Use of illicit drugs or on-going alcohol use * Vomiting within the 24 hours prior to cisplatin infusion * Evidence of clinically significant congestive heart failure (Patients must be able to tolerate hydration with cisplatin) * Peripheral Neuropathy \> Grade 2 * Significant hearing loss * Pregnant or breast-feeding women * Patients may be enrolled in additional clinical trials, as long as no additional investigational agents are being used * Patients with a hypersensitivity to fosaprepitant, aprepitant, polysorbate, and any other components of the EMEND product * The following therapies are excluded during the treatment phase of the study: investigational agents; anti-neoplastic or anti-tumor agents, including immunotherapy, and hormonal anti-cancer therapy; additional scheduled anti-emetic medications, unless needed as rescue medications for acute or delayed nausea/vomiting * Strong Inhibitors of CYP3A4: ketoconazole, itraconazole, clarithromycin, ritonavir, and nelfinavir; strong Inducers of CYP3A4: rifampin, carbamazepine, and phenytoin
References
Publications (0)
Data not yet available