Study to Analyze Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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/m2, with or without other chemotherapy agent(s); or 
    • Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2).
  • 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:
    • has not undergone a hysterectomy or bilateral oophorectomy; or
    • 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 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 prochloperazine 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.
  • Age ≥ 18 years old
  • ECOG Performance Status 0, 1 or 2.
  • Patients must be able to read and comprehend English. Local translation, including verbal translation of PROs is not permitted.
  • Required Initial Laboratory Values ≤120 days prior to registration Serum Creatinine ≤ 2.0 mg/dL .
  • AST or ALT ≤ 3 x upper limit of normal (ULN).

Exclusion Criteria:

  • Any non-compliance with Inclusion Criteria above.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

La Crosse, Wis.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Closed for enrollment

Contact information:

Alzheimer’s Disease Research Center

(507) 284-1324

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions