NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

URCC-16070 - "Treatment of Refractory Nausea"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.

 



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Cancer Control Clinical Trial

CANCER TYPE: Breast
RESEARCH BASE: URCC
NCT NUMBER: NCT03367572
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Nausea in breast ca patients receiving chemo, netupitant/palonosetron + dexamethasone +/- prochlorperazine or olanzapine.



NOTES


Treatment     (Supplied drug: prochlorperazine, olanzapine, Akynzeo, and dexamethasone)

If patient scores ≥3 on nausea scale after 1st cycle of chemo, they will be randomized to 1 of 3 arms:

Arm 1:

 

Day 1: One 300mg capsule netupitant/palonosetron approximately 1 hour prior to chemotherapy + dexamethasone 12mg PO 30 minutes prior to chemotherapy + placebo1 + placebo2 q8h

Days 2 - 4: (Dexamethasone 8mg + placebo1) qam+ placebo2 q8h

Arm 2:

Day 1: One 300mg capsule netupitant/palonosetron approximately 1 hour prior to chemotherapy + dexamethasone 12mg PO 30 minutes prior to chemotherapy + placebo1 + prochlorperazine 10mg q8h

Days 2 - 4: (Dexamethasone 8mg + placebo1) qam + prochlorperazine 10mg q8h

Arm 3:

Day 1: One 300mg capsule netupitant/palonosetron approximately 1 hour prior to chemotherapy + dexamethasone 12mg PO 30 minutes prior to chemotherapy + olanzapine 10mg + placebo2 q8h

Days 2 - 4: (Dexamethasone 8mg + olanzapine) qam 10mg + placebo2 q8h

 



ELIGIBILITY

Cycle 1 Eligibility

  • Have a diagnosis of breast cancer and be chemotherapy naïve. 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. 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 ASCO Clinical Practice Guidelines at Cycle 1.(1) [The relevant ASCO Antiemetic Guidelines are included in the supporting documents section of the protocol webpage.]
  • Be able to read English (because the assessment materials are in printed format.) In addition, materials will not be provided in Spanish because validated translations of most of the study measures are not available in Spanish, and Spanish translating capacity is not available at all affiliate sites.
  • Be at least 18 years of age.
  • Be female.
  • Have the ability to give written informed consent.
  • Have ECOG performance status of 0, 1, or 2
  • Because the NCCN antiemetic guidelines(11) state that olanzapine should be used with caution in elderly patients, patients 80 years of age or older must have approval from an oncologist or their designee to participate in this study.
  • Because aprepitant can lower International Normalized Ratio (INR) levels if taken concurrently with warfarin, 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.
  • No clinical evidence of current or impending bowel obstruction.
  • No known history of central nervous system disease (e.g., brain metastases or a seizure disorder.)
  • No dementia.
  • No uncontrolled diabetes mellitus or uncontrolled hyperglycemia.
  • No severe hepatic impairment, severe renal impairment, or end-stage renal disease as determined by the treating physician.
  • No treatment 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). (A partial list of antipsychotic agents is included in the supporting documents section of the protocol webpage.)
  • No known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months.
  • No benzodiazepines. (A partial list of benzodiazepines is included in the supporting documents section of the protocol webpage.)
  • No anticholinergic medications. (A partial list of anticholinergic medications is included in the supporting documents section of the protocol webpage.)
  • Not receiving quinolone antibiotic therapy. (A partial list of quinolone antibiotics is included in the supporting documents section of the protocol webpage.)
  • Not taking amifostine (Ethiofos).
  • No known hypersensitivity to olanzapine or to phenothiazines.

Cycle 2 Eligibility

  • Only participants with a nausea score > 3 at least once on the diary assessment from Cycle 1 can be randomized for Cycle 2.
  • Participants must be scheduled to receive the same chemotherapy regimen as received at Cycle 1.
  • Must not have received Akynzeo® at Cycle 1.
  • Must still meet all the eligibility criteria for Cycle 1.

 






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