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A Phase IV Trial of Cesametâ„¢ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting


Phase 4
18 Years
65 Years
Not Enrolling
Both
Nausea and Vomiting

Thank you

Trial Information

A Phase IV Trial of Cesametâ„¢ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting


Inclusion Criteria:



1. Patients must have signed an IRB-approved informed consent.

2. 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 .

3. Patients must have an ECOG Performance Status of 0 or 1 (see Appendix I).

4. Patients must be >18 years of age.

5. 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.

6. Patients of childbearing potential must agree to use effective contraceptive measures
during study treatment and for a reasonable time thereafter.

7. Patients must have adequate bone marrow function based on requirements specified in
prescribing guidelines for the chemotherapy regimen.

8. Patients must have adequate renal and hepatic function based on requirements
specified in prescribing guidelines for the chemotherapy regimen.

Exclusion Criteria:

1. Patients with pre-existing nausea or vomiting.

2. Patients with other potential causes of nausea or vomiting, including uncontrolled
brain metastases, bowel obstruction, or gastrointestinal hemorrhage.

3. Patients with prior adjuvant chemotherapy.

4. Patients receiving concurrent radiotherapy to the brain or upper abdomen.

5. Patients currently taking other antiemetics.

6. Patients who have a history of hypersensitivity to a cannabinoid.

7. Patients with a serious uncontrolled intercurrent medical illness, including serious
infection.

8. 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.

9. Patients with hypertension or heart disease, since Cesamet can elevate supine and
standing heart rates and cause postural hypotension.

10. Patients with a history of other malignancy within the last 5 years, which could
affect the diagnosis or assessment of these study drugs.

11. Any patient who is pregnant or lactating.

12. Any patient who is unable to comply with the requirements of the study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To demonstrate incremental improvement with Cesamet in control of chemotherapy induced nausea and vomiting in patients who have failed to respond adequately to standard antiemetic regimens.

Outcome Time Frame:

unk

Safety Issue:

No

Principal Investigator

Ralph Boccia, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Cancer and Blood Disorders

Authority:

United States: Institutional Review Board

Study ID:

I-05-017

NCT ID:

NCT00418678

Start Date:

August 2006

Completion Date:

December 2007

Related Keywords:

  • Nausea and Vomiting
  • Nausea
  • Vomiting

Name

Location

Veeda OncologyColumbus, Ohio  43215