Status:
TERMINATED
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
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Nausea and Vomiting
Stage III Squamous Cell Carcinoma of the Hypopharynx
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the complete response rate of anti-emetic therapy based on a single dose of intravenous fosaprepitant with multiple cycles of high dose cisplatin (complete respons...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00895245
Start Date
February 1 2009
End Date
February 1 2011
Last Update
May 18 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109