Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Breakthrough Nausea and Vomiting (CINV) in Patients Receiving Moderately or Highly Emetogenic Chemotherapy: A Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of participants with a previous history of emetic episodes
研究概览
简要总结
Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific patient characteristics such as female gender, age, and history of low alcohol intake can increase a patients' risk for CINV.
GERSC is a new, subcutaneously (SC) administered polymeric formulation of Granisetron that was developed to provide slow, controlled, and sustained release of Granisetron to prevent both acute and delayed CINV associated with moderately emetic chemotherapy (MEC) and highly emetic chemotherapy (HEC)
详细描述
All patients eligible for the study receiving moderately emetogenic (MEC) chemotherapy will receive GERSC receptor antagonist on day one. All patients eligible for the study receiving highly emetogenic Chemotherapy (HEC) chemotherapy will receive GERSC receptor antagonist on day one including dexamethasone and NK-1 Receptor antagonist during cycle 1.
The primary objective is to measure the Complete Response (no emetic episodes, no use of rescue medications) in patients receiving GERSC as a replacement for the second generation 5 HT3 receptor antagonist palonosetron used in the first chemotherapy cycle for those patients receiving MEC or HEC and developed Breakthrough CINV. Complete response would be recorded specifically for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy), and overall periods (0-120 hours post-chemotherapy).
This study has two study groups.
- Group 1 (HEC) will receive GERSC, dexamethasone and NK-1 antagonist prior to chemotherapy
- Group 2 (MEC) will receive GERSC and dexamethasone prior to chemotherapy
During the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of malignant disease and scheduled for MEC or HEC
- •Chemotherapy naive
- •Age ≥18 years.
- •ECOG Performance Status 0 or 1
- •Required Initial Laboratory Values ≤28 days prior to registration. Patient must have adequate bone marrow, kidney, and liver function as evidenced by:
- •Platelet count ≥ 100,000/ mm3
- •Bilirubin ≤ 1.5 x ULN, except for subjects with Gilbert's syndrome
- •Serum Creatinine ≤2.0 mg/dL
- •SGOT or SGPT ≤3 x upper limit of normal (ULN)
- •Absolute neutrophil count (ANC) ≥1500/mm3
- •Patients receiving HEC will have received the 5HT3 receptor antagonist palonosetron, a NK-1, and dexamethasone as antiemetic prophylaxis during cycle 1 of chemotherapy
- •Patients receiving MEC will have received the 5HT3 receptor antagonist palonosetron, and dexamethasone as antiemetic prophylaxis during cycle 1 of chemotherapy
排除标准
- •No nausea or vomiting ≤ 24 hours prior to registration.
- •Negative pregnancy test (serum β hCG) done ≤7 days prior to registration, for women of childbearing potential only (per clinician discretion).
- •No severe cognitive compromise.
- •No known history of active, untreated CNS disease (e.g. brain metastases, seizure disorder).
- •No concurrent use of amifostine, thioridazine, pimozide or St. John's wort.
- •No concurrent abdominal radiotherapy.
- •No concurrent use of olanzapine therapy.
- •No chronic alcoholism (as determined by the investigator).
- •No known hypersensitivity to granisetron.
- •No known uncontrolled cardiac arrhythmia or uncontrolled congestive heart failure.
- •No acute myocardial infarction within the previous six months.
- •No history of uncontrolled diabetes mellitus (may be on a stable dose of insulin or on a stable dose of an oral hypoglycemic agent).
- •Patients with psychiatric illness that would prevent the patient from giving informed consent are not eligible for the trial
- •Medical condition such as uncontrolled infection (including HIV),uncontrolled Diabetes Mellitus, unstable cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient are not eligible for the trial
- •Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible for the trial; Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
- •Patients who cannot swallow oral formulations of the agent(s) are not eligible for the trial.
研究组 & 干预措施
GERSC for patients receiving highly emetogenic chemotherapy
Participants will receive GERSC, and two other standard antiemetics prior to chemotherapy
干预措施: GRANISETRON EXTENDED RELEASE INJECTION (GERSC) (Drug)
GERSC on patients receiving moderately emetogenic chemotherapy
Participants will receive GERSC and one other standard antiemetic prior to chemotherapy
干预措施: GRANISETRON EXTENDED RELEASE INJECTION (GERSC) (Drug)
结局指标
主要结局
Percentage of participants with a previous history of emetic episodes
时间窗: Baseline assessment
After participants have completed their informed consent, they will complete a baseline assessment to record emetic episodes prior to chemotherapy.
Percentage of participants with a complete response of no emetic episode
时间窗: Day 1 through Day 6
Patient will be monitored for total vomiting episodes starting from Day 1 through Day 6 after receiving chemotherapy. The participants will complete a vomiting assessment and record the number of episodes (none, once, more than once and number)
次要结局
- Percentage of participants frequency rate of No Nausea(Day 1 through Day 6)
- Percentage of participants experiencing GERSC toxicity(Baseline through 30 days)
研究者
Rudolph Navari
Professro
University of Alabama at Birmingham