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

NCT00895245 | Terminated Phase 2 Results

• 2 other identifiers: 6862NCI-2009-01669
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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

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

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen

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

  120 hours following cisplatin infusion

Secondary Outcomes (3)

• Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)

  25-120 hours following cisplatin infusion

• Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale

  120 hours following cisplatin infusion

• Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire

  5 days following cisplatin infusion

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: fosaprepitant dimeglumine; Drug: cisplatin; Drug: palonosetron hydrochloride; Drug: dexamethasone; Other: Functional Living Index-Emesis Questionnaire; Behavioral: Emesis Diary; Radiation: Radiotherapy

Interventions

fosaprepitant dimeglumine DRUG

Given IV

Arm I

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP, Neoplatin

Arm I

palonosetron hydrochloride DRUG

Given IV

Also known as: Aloxi, RS 25259-197

Arm I

dexamethasone DRUG

Given IV and orally

Also known as: Aeroseb-Dex, Decaderm, Decadron, Decaspray, DM, DXM

Arm I

Functional Living Index-Emesis Questionnaire OTHER

Ancillary studies

Arm I

Emesis Diary BEHAVIORAL

Ancillary studies

Arm I

Radiotherapy RADIATION

Undergo radiotherapy

Also known as: 3-D conformal radiotherapy or IMRT

Arm I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting; Squamous Cell Carcinoma of Head and Neck

Interventions

fosaprepitant; Cisplatin; Palonosetron; Dexamethasone; Calcium Dobesilate; Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Therapeutics; Radiotherapy, Computer-Assisted

Limitations and Caveats

This study was terminated early due to lack of efficacy.

Results Point of Contact

• Title: Dr. Keith Eaton
• Organization: University of Washington

kdeaton@uw.edu

206-288-2048

Study Officials

• Keith Eaton

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: February 1, 2011
• Last Updated: May 18, 2017
• Results First Posted: May 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)