Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting

• Status: Withdrawn
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Heron Therapeutics
• Treatments: Antiemetics; Emetics; Granisetron

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.