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NCT00895245 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-05-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Drug: fosaprepitant dimeglumine
    2. Drug: cisplatin
    3. Drug: palonosetron hydrochloride
    4. Drug: dexamethasone
    5. Other: Functional Living Index-Emesis Questionnaire
    6. Behavioral: Emesis Diary
    7. Radiation: Radiotherapy
    label
    Arm I
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    fosaprepitant dimeglumine
    type
    DRUG
  2. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    cisplatin
    other Names
    1. CACP
    2. CDDP
    3. CPDD
    4. DDP
    5. Neoplatin
    type
    DRUG
  3. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    palonosetron hydrochloride
    other Names
    1. Aloxi
    2. RS 25259-197
    type
    DRUG
  4. arm Group Labels
    1. Arm I
    description
    Given IV and orally
    name
    dexamethasone
    other Names
    1. Aeroseb-Dex
    2. Decaderm
    3. Decadron
    4. Decaspray
    5. DM
    6. DXM
    type
    DRUG
  5. arm Group Labels
    1. Arm I
    description
    Ancillary studies
    name
    Functional Living Index-Emesis Questionnaire
    type
    OTHER
  6. arm Group Labels
    1. Arm I
    description
    Ancillary studies
    name
    Emesis Diary
    type
    BEHAVIORAL
  7. arm Group Labels
    1. Arm I
    description
    Undergo radiotherapy
    name
    Radiotherapy
    other Names
    1. 3-D conformal radiotherapy or IMRT
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
6
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.
    measure
    Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen
    time Frame
    120 hours following cisplatin infusion
secondary Outcomes
  1. measure
    Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)
    time Frame
    25-120 hours following cisplatin infusion
  2. description
    The visual analog scale ranges from 0-100. 0 is labeled as "no nausea" and 100 is labeled as "nausea as bad as it could be" A score of \< 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion.
    measure
    Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale
    time Frame
    120 hours following cisplatin infusion
  3. description
    FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \>108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.
    measure
    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
    time Frame
    5 days following cisplatin infusion
Full study description
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.
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 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.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice