Malignant Neoplasm
Conditions
Brief summary
This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if olanzapine when given with other drugs, is still effective without using fosaprepitant dimeglumine for controlling nausea and vomiting.
Detailed description
PRIMARY OBJECTIVES: I. To compare between the two study arms the proportion of patients with no nausea for the overall (0-120 hours post-chemotherapy), acute (0-24 hours post-chemotherapy), and delayed periods (24-120 hours post-chemotherapy) for patients receiving highly emetogenic chemotherapy (HEC). SECONDARY OBJECTIVES: I. To compare between the two study arms the complete response (CR) rates (no emetic episodes and no use of rescue medication) in the acute, delayed, and overall periods. II. To compare between the two study arms, the incidences of potential toxicities that have been ascribed to olanzapine. III. To perform an economic evaluation of olanzapine and fosaprepitant dimeglumine (fosaprepitant) versus (vs.) olanzapine in patients receiving HEC (noting that all patients will also receive dexamethasone and a 5HT3 receptor antagonist). IV. To explore the efficacy of olanzapine in chemotherapy cycles two to four, for patients who elect to continue on the same antiemetic regimen received in cycle one, in chemotherapy cycles two to four (continuation phase), by documenting nausea and complete response. V. To explore the safety of olanzapine in chemotherapy cycles two to four, for patients who elect to continue on the same antiemetic regimen received in cycle one, in chemotherapy cycles two to four (continuation phase), by recording any adverse events or drug related toxicities. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive palonosetron hydrochloride intravenously (IV) over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or orally (PO) on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed up periodically.
Interventions
Given IV
Given IV or PO
DRUGDexamethasone
Given PO
Given IV
DRUGOlanzapine
Given PO
OTHERPlacebo
Given IV
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of malignant disease of any stage; (stage I through stage IV) * No prior history of chemotherapy for any malignancy * Scheduled to receive intravenous HEC (highly emetogenic chemotherapy) (either cisplatin-containing regimen or doxorubicin and cyclophosphamide \[AC\]); cisplatin, given on a single day, at a dose of \>= 70 mg/m\^2, with or without other chemotherapy agent(s) OR doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) * No nausea or vomiting =\< 24 hours prior to registration * Negative pregnancy test (serum or urine) done =\< 7 days prior to registration, for women of childbearing potential only \* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * No known diagnosis of dementia; patients with stable treated brain metastases are eligible to participate * No known history of central nervous system (CNS) disease (e.g. seizure disorder) * No treatment with another antipsychotic agent such as olanzapine, risperidone, quetiapine, clozapine, phenothiazine or butyrophenone =\< 30 days prior to registration * No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy but not within 24 hours prior to registration) * No use of amifostine within 7 days prior to registration * No radiotherapy within 7 days prior to registration or planned for one week after the current dose of chemotherapy * No use of quinolone antibiotic therapy within 7 days prior to registration * No chronic alcoholism (as determined by the investigator) * No known hypersensitivity to olanzapine * No known uncontrolled cardiac arrhythmia, no known uncontrolled congestive heart failure, or no acute myocardial infarction within the previous six months * No history of uncontrolled diabetes mellitus, i.e., no diabetic ketoacidosis; within 6 months prior to registration; patients are eligible if they have controlled diabetes on diet, oral agents, and/or insulin * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Patients must be able to read and comprehend English; local translation, including verbal translation of patient-reported outcomes (PROs) is not permitted * Serum creatinine =\< 2.0 mg/dL =\< 120 days prior to registration * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN) =\< 120 days prior to registration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Up to 120 hours | The specific measure will be based on the proportion of patients with a value of 0, as measured by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Questionnaire. A modified intent-to-treat principle will be applied for statistical analysis of efficacy in evaluable patients. The proportions of patients with no nausea during the overall, the acute, and the delayed period will be summarized by treatment arm. They will be tested in a sequential manner, using a Simes gatekeeping procedure to maintain the overall significance level at the specified by the Lan-DeMets family of alpha spending function. The difference in no nausea proportions between arms will be estimated along with a one-sided 95% confidence interval. The tests and the confidence intervals will be constructed using normal approximation of the binomial distribution adjusted for the non-inferiority margin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Up to 120 hours | The specific measure will be based on the proportion of patients who answered None to both questions concerning Vomiting episode(None, Once, Twice, More than twice) and number of extra nausea/vomiting pills taken (None, One, Two, More than two) in the Nausea and Vomiting Daily Diary/Questionnaire. The CR rate for the overall, the acute, and the delayed period will be summarized by treatment arm and will be compared using a Chi-squared test. The difference in CR rates between arms will be estimated along with a 95% confidence interval. |
| Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Up to 120 hours | Potential toxicities includes nausea, undesired sedation, and undesired appetite, measured by three individual items ( nausea, undesired sedation, undesired appetite) of the Nausea and Vomiting Daily Dairy/Questionnaire(scale 0-10, 0 is no symptoms, 10 is worst symptoms). Incidences of toxicities will be summarized by type and by treatment arm. Incidences of toxicities will be compared between arms using a Chi-squared test or the Fisher's exact test as appropriate. In addition, undesired sedation and appetite increase as collected in the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed by repeated measures analyses including descriptive statistics, graphical approaches, and growth curve models to account for the factor of day and time trend. |
| Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Up to 1 year | The specific measure will be based on the by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Nausea and Vomiting Daily Diary/Questionnaire. Nausea scores (0-10) repeatedly measured by the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed using the repeated measures analyses and growth curve models as described above for undesired sedation and increase in appetite. |
| Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Over 5 Days per each of the 4 cycles | The specific measure will be based on the single item : number of extra nausea/vomiting pills taken (None, One , Twice, More than twice) of the Nausea and Vomiting Daily Diary/Questionnaire. |
Countries
Guam, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>\>
\>\> Palonosetron Hydrochloride: Given IV\>\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>\>
\>\> Dexamethasone: Given PO\>\>
\>\> Fosaprepitant Dimeglumine: Given IV\>\>
\>\> Olanzapine: Given PO | 346 |
| Arm II (Placebo, Olanzapine) Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>\>
\>\> Palonosetron Hydrochloride: Given IV\>\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>\>
\>\> Dexamethasone: Given PO\>\>
\>\> Olanzapine: Given PO\>\>
\>\> Placebo: Given IV | 344 |
| Total | 690 |
Baseline characteristics
| Characteristic | Total | Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Arm II (Placebo, Olanzapine) |
|---|---|---|---|
| 5-HT Receptor Antagonist Ondansetron | 180 Participants | 90 Participants | 90 Participants |
| 5-HT Receptor Antagonist Palonosetron | 510 Participants | 256 Participants | 254 Participants |
| Age, Continuous | 56.3 years STANDARD_DEVIATION 11.34 | 56.5 years STANDARD_DEVIATION 11.1 | 56.1 years STANDARD_DEVIATION 11.58 |
| Chemotherapy Regimen Anthracycline and cyclophosphamide (AC) | 533 Participants | 267 Participants | 266 Participants |
| Chemotherapy Regimen Cisplatin-containing regimen | 157 Participants | 79 Participants | 78 Participants |
| ECOG Performance Score 0 | 557 Participants | 276 Participants | 281 Participants |
| ECOG Performance Score 1 | 126 Participants | 67 Participants | 59 Participants |
| ECOG Performance Score 2 | 7 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 656 Participants | 331 Participants | 325 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 24 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 36 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 12 Participants | 11 Participants |
| Race (NIH/OMB) White | 570 Participants | 292 Participants | 278 Participants |
| Sex: Female, Male Female | 578 Participants | 289 Participants | 289 Participants |
| Sex: Female, Male Male | 112 Participants | 57 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 286 | 2 / 291 |
| other Total, other adverse events | 252 / 286 | 248 / 291 |
| serious Total, serious adverse events | 51 / 286 | 60 / 291 |
Outcome results
Primary
No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods
The specific measure will be based on the proportion of patients with a value of 0, as measured by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Questionnaire. A modified intent-to-treat principle will be applied for statistical analysis of efficacy in evaluable patients. The proportions of patients with no nausea during the overall, the acute, and the delayed period will be summarized by treatment arm. They will be tested in a sequential manner, using a Simes gatekeeping procedure to maintain the overall significance level at the specified by the Lan-DeMets family of alpha spending function. The difference in no nausea proportions between arms will be estimated along with a one-sided 95% confidence interval. The tests and the confidence intervals will be constructed using normal approximation of the binomial distribution adjusted for the non-inferiority margin.
Time frame: Up to 120 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Overall No Nausea | 123 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Overall Any Nausea | 203 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Acute No Nausea | 202 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Acute Any Nausea | 124 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Delayed Any Nausea | 186 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Delayed No Nausea | 140 Participants |
| Arm II (Placebo, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Acute Any Nausea | 119 Participants |
| Arm II (Placebo, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Overall No Nausea | 97 Participants |
| Arm II (Placebo, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Delayed No Nausea | 114 Participants |
| Arm II (Placebo, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Overall Any Nausea | 223 Participants |
| Arm II (Placebo, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Acute No Nausea | 201 Participants |
| Arm II (Placebo, Olanzapine) | No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods | Delayed Any Nausea | 206 Participants |
Secondary
Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire
The specific measure will be based on the by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Nausea and Vomiting Daily Diary/Questionnaire. Nausea scores (0-10) repeatedly measured by the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed using the repeated measures analyses and growth curve models as described above for undesired sedation and increase in appetite.
Time frame: Up to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire | 0.8211364 score on a scale | Standard Deviation 1.6289005 |
| Arm II (Placebo, Olanzapine) | Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire | 0.9177778 score on a scale | Standard Deviation 1.7821806 |
Secondary
Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
The specific measure will be based on the proportion of patients who answered None to both questions concerning Vomiting episode(None, Once, Twice, More than twice) and number of extra nausea/vomiting pills taken (None, One, Two, More than two) in the Nausea and Vomiting Daily Diary/Questionnaire. The CR rate for the overall, the acute, and the delayed period will be summarized by treatment arm and will be compared using a Chi-squared test. The difference in CR rates between arms will be estimated along with a 95% confidence interval.
Time frame: Up to 120 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Complete Response - >> Overall | 179 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Complete Response - >> Acute | 256 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Complete Response ->> Delayed | 193 Participants |
| Arm II (Placebo, Olanzapine) | Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Complete Response - >> Overall | 151 Participants |
| Arm II (Placebo, Olanzapine) | Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Complete Response ->> Delayed | 166 Participants |
| Arm II (Placebo, Olanzapine) | Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Complete Response - >> Acute | 247 Participants |
Secondary
Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Potential toxicities includes nausea, undesired sedation, and undesired appetite, measured by three individual items ( nausea, undesired sedation, undesired appetite) of the Nausea and Vomiting Daily Dairy/Questionnaire(scale 0-10, 0 is no symptoms, 10 is worst symptoms). Incidences of toxicities will be summarized by type and by treatment arm. Incidences of toxicities will be compared between arms using a Chi-squared test or the Fisher's exact test as appropriate. In addition, undesired sedation and appetite increase as collected in the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed by repeated measures analyses including descriptive statistics, graphical approaches, and growth curve models to account for the factor of day and time trend.
Time frame: Up to 120 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Overall Any Appetite Increase | 186 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Acute Any Appetite Increase | 91 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Overall No Appetite Increase | 140 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Acute No Appetite Increase | 235 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Delayed No Appetite Increase | 147 Participants |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Delayed Any Appetite Increase | 179 Participants |
| Arm II (Placebo, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Overall No Appetite Increase | 136 Participants |
| Arm II (Placebo, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Overall Any Appetite Increase | 184 Participants |
| Arm II (Placebo, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Delayed No Appetite Increase | 143 Participants |
| Arm II (Placebo, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Acute Any Appetite Increase | 84 Participants |
| Arm II (Placebo, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Delayed Any Appetite Increase | 177 Participants |
| Arm II (Placebo, Olanzapine) | Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Acute No Appetite Increase | 236 Participants |
Secondary
Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
The specific measure will be based on the single item : number of extra nausea/vomiting pills taken (None, One , Twice, More than twice) of the Nausea and Vomiting Daily Diary/Questionnaire.
Time frame: Over 5 Days per each of the 4 cycles
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Zero | 3614 episodes |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Two | 170 episodes |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | One | 350 episodes |
| Arm I (Fosaprepitant Dimeglumine, Olanzapine) | Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | More than two | 56 episodes |
| Arm II (Placebo, Olanzapine) | Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | One | 405 episodes |
| Arm II (Placebo, Olanzapine) | Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Zero | 3541 episodes |
| Arm II (Placebo, Olanzapine) | Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | More than two | 74 episodes |
| Arm II (Placebo, Olanzapine) | Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Two | 162 episodes |