Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,363
- 试验地点
- 18
- 主要终点
- Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
研究概览
简要总结
This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To determine if control of nausea at cycle 2 in participants who experienced chemotherapy-induced nausea and vomiting (CINV) at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.
SECONDARY OBJECTIVES:
I. To determine if olanzapine is more effective than prochlorperazine in controlling nausea at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.
II. To determine if control of vomiting at cycle 2 in patients who experienced CINV at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of breast cancer and be chemotherapy naive; NOTE: prior methotrexate for non-cancerous conditions is allowed
- •Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin. Single-day chemotherapy is defined as only one infusion or injection per cycle. Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens
- •Be scheduled to receive an antiemetic regimen that does not contain Akynzeo; in addition, the antiemetic regimen must conform with American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines at cycle 1
- •Be able to read English
- •Have the ability to give written informed consent
- •Have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •NOTE: patients 80 years of age or older must have approval from an oncologist or their designee to participate in this study
- •NOTE: patients currently receiving warfarin must have approval from an oncologist or their designee to participate in this study
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for the duration of the study and have a negative pregnancy test within 10 days prior to the initiation of chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- •CYCLE II PORTION ONLY: Only participants with a nausea score >= 3 at least once on the diary assessment from cycle 1 can be randomized for cycle 2
- •CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1
排除标准
- •Have clinical evidence of current or impending bowel obstruction
- •Have a known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
- •Have dementia
- •Have uncontrolled diabetes mellitus or uncontrolled hyperglycemia
- •Have severe hepatic impairment, severe renal impairment, or end-stage renal disease as determined by the treating physician
- •Have had long term treatment (> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =< 5 days)
- •Have a known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months
- •Be taking benzodiazepines regularly (> 5 days within the past 30 days); pro re nata (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms, or as a rescue medication for breakthrough CINV is allowed
- •Be taking anticholinergic medications
- •Be receiving quinolone antibiotic therapy
- •Be taking amifostine (Ethiofos)
- •Have a known hypersensitivity to olanzapine or to phenothiazines
- •CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 1
- •CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1
研究组 & 干预措施
Group II (net/pal hydro, dexa, prochlorperazine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (netupitant/palonosetron hydrochloride, dexamethasone
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
干预措施: Dexamethasone (Drug)
Group II (net/pal hydro, dexa, prochlorperazine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
干预措施: Netupitant/Palonosetron Hydrochloride (Drug)
Group I (netupitant/palonosetron hydrochloride, dexamethasone
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (netupitant/palonosetron hydrochloride, dexamethasone
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
干预措施: Netupitant/Palonosetron Hydrochloride (Drug)
Group I (netupitant/palonosetron hydrochloride, dexamethasone
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
干预措施: Placebo (Other)
Group I (netupitant/palonosetron hydrochloride, dexamethasone
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
干预措施: Quality-of-Life Assessment (Other)
Group II (net/pal hydro, dexa, prochlorperazine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
干预措施: Dexamethasone (Drug)
Group II (net/pal hydro, dexa, prochlorperazine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
干预措施: Placebo (Other)
Group II (net/pal hydro, dexa, prochlorperazine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
干预措施: Prochlorperazine (Drug)
Group II (net/pal hydro, dexa, prochlorperazine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
干预措施: Quality-of-Life Assessment (Other)
Group III (net/pal hydro, dexa, olanzapine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
干预措施: Dexamethasone (Drug)
Group III (net/pal hydro, dexa, olanzapine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
干预措施: Laboratory Biomarker Analysis (Other)
Group III (net/pal hydro, dexa, olanzapine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
干预措施: Netupitant/Palonosetron Hydrochloride (Drug)
Group III (net/pal hydro, dexa, olanzapine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
干预措施: Olanzapine (Drug)
Group III (net/pal hydro, dexa, olanzapine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
干预措施: Placebo (Other)
Group III (net/pal hydro, dexa, olanzapine, placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
时间窗: Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)
Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
Average Nausea Defined as the [AVERAGE] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
时间窗: Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)
Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
次要结局
- The Secondary Outcome Variable Will be [ MAXIMUM ] Nausea (Measured on a 7-point Scale Anchored by ("1:Not at All Nauseated" and 7:"Extremely Nauseated"). Difference of Average Nausea Between Control and Experimental Arms Will be Calculated and Compared.(Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4))
- Vomiting (Yes/No) at Cycle 2 in Participants Who Experienced CINV at Cycle 1.(Vomiting measured at Cycle 1 Chemotherapy (Yes/No on Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (Yes/No on Days 1,2,3,4))
研究者
Luke Peppone
Associate Professor of Surgery and Orthopaedics
University of Rochester NCORP Research Base