Status:
TERMINATED
A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
Lead Sponsor:
Veeda Oncology
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Nausea and Vomiting
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a Phase IV, open-label, sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer. (See Section 4.2.1 f...
Eligibility Criteria
Inclusion
- Patients must have signed an IRB-approved informed consent.
- Patients must be receiving moderately emetogenic chemotherapy for the first time with one of the following neoplasms/regimens:
- Non-small cell lung cancer receiving paclitaxel and carboplatin
- Breast cancer receiving cyclophosphamide and doxorubicin
- Colorectal cancer receiving a FOLFOX regimen .
- Patients must have an ECOG Performance Status of 0 or 1 (see Appendix I).
- Patients must be \>18 years of age.
- Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
- Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
- Patients must have adequate bone marrow function based on requirements specified in prescribing guidelines for the chemotherapy regimen.
- Patients must have adequate renal and hepatic function based on requirements specified in prescribing guidelines for the chemotherapy regimen.
Exclusion
- Patients with pre-existing nausea or vomiting.
- Patients with other potential causes of nausea or vomiting, including uncontrolled brain metastases, bowel obstruction, or gastrointestinal hemorrhage.
- Patients with prior adjuvant chemotherapy.
- Patients receiving concurrent radiotherapy to the brain or upper abdomen.
- Patients currently taking other antiemetics.
- Patients who have a history of hypersensitivity to a cannabinoid.
- Patients with a serious uncontrolled intercurrent medical illness, including serious infection.
- Patients with a current or previous psychiatric disorder (including manic depressive illness and schizophrenia), as the symptoms of these disease states may be unmasked by the use of cannabinoids. Cesamet should be used with caution in individuals receiving other psychoactive drugs.
- Patients with hypertension or heart disease, since Cesamet can elevate supine and standing heart rates and cause postural hypotension.
- Patients with a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of these study drugs.
- Any patient who is pregnant or lactating.
- Any patient who is unable to comply with the requirements of the study.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00418678
Start Date
August 1 2006
End Date
December 1 2007
Last Update
December 2 2010
Active Locations (1)
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1
Veeda Oncology
Columbus, Ohio, United States, 43215