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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Nausea and Vomiting, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx

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Trial Information

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


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 response is
defined as no emesis or rescue nausea medications needed in the 120 hours following
cisplatin infusion).

SECONDARY 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 in the delayed period
(25-120 hours following cisplatin infusion).

II. To determine efficacy of anti-emetic therapy based on a single-dose of intravenous
fosaprepitant to achieve adequate control of nausea following multiple cycles of high-dose
cisplatin as defined by a score on the visual analog scale of < 25mm in the 120 hours
following cisplatin infusion.

III. To determine the functional impact of cisplatin induced nausea and vomiting (CINV) on
daily life as measured by the Functional Living Index-Emesis (FLIE) Questionnaire total
score.

OUTLINE: Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3
courses. Patients also undergo 3-D conformal radiotherapy or intensity-modulated
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 (prior to cisplatin infusion). 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 (that includes a nausea visual analog scale) daily for 5
days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis
Questionnaire on day 8 of each course of chemotherapy.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Proportion of patients with a complete response to the anti-emetic medication regimen

Outcome Time Frame:

Up to day 27

Safety Issue:

No

Principal Investigator

Keith Eaton

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

6862

NCT ID:

NCT00895245

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Nausea and Vomiting
  • Stage III Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Squamous Cell Carcinoma of the Larynx
  • Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage III Squamous Cell Carcinoma of the Nasopharynx
  • Stage III Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Nausea
  • Vomiting
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109