Status:
WITHDRAWN
Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Heron Therapeutics
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 specifi...
Detailed Description
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 emetogeni...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04085393
Start Date
August 15 2020
End Date
December 1 2022
Last Update
September 30 2020
Active Locations (1)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294