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Study Summary
No. 2006-0841:.......Nausea......Phuong Khanh Morrow......Breast Medical Oncology
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Study Summary Title
Study Summary
Number:
2006-0841
Study Title:Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/Dexamethasone with or without Dronabinol for the Prevention of Chemotherapy-induced Nausea and Vomiting after Moderately Emetogenic Chemotherapy
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Physician New Patient Referral
Name:Phuong Khanh MorrowPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Breast Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2817
Contact us about clinical trials
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General Information
Disease Group:NauseaSupported By:NCI
Solvay Pharmaceuticals, Inc.
Phase of Study:Phase IIIReturn
Visit:
0
Treatment
Agents:
Dexamethasone
Dronabinol
Palonosetron
Home Care:Patients will be taking dronabinol for 5 days prior to chemo, which may
possibly be at home prior to coming in for treatment.
Treatment Loc:Both at MDACC & Community Programs (CCOP/Network)
Estimated
Length of Stay
in Houston:
N/A. This is an outpatient population
Description/
Intervention:
The goal of this clinical research study is to learn if adding dronabinol in
combination with the standard of care (dexamethasone and palonosetron) can
better help to control nausea and vomiting in patients receiving chemotherapy.
The safety of the drug combinations will also be studied.
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Study Objectives / Outcomes
1. To determine whether dronabinol can add significantly to the antiemetic protection provided by a standard palonosetron and dexamethasone regimen for patients receiving moderately emetogenic chemotherapy.
2. To determine the tolerability of dronabinol when added to a regimen of dexamethasone and palonosetron administered for the prevention of acute and delayed nausea and vomiting caused by moderately emetogenic chemotherapy. Tolerability will be evaluated by investigating whether there are treatment-limiting toxicities observed with three drug combination.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:05/13/2008
Study Type:Phase Iii
Recruitment Status:Closed
Projected Accrual:200
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Histologically or cytologically documented solid tumor

2) Receiving moderately emetogenic chemotherapy for the first time: Patients may be chemotherapy naive, or patients may have previously received a mildly emetogenic agent (such as a taxane) if no nausea/vomiting was experienced with that chemotherapy

3) Scheduled to receive cyclophosphamide </= 1500 mg/m^2 IV and/or doxorubicin >/= 40 mg/m^2 IV given as single doses on Day 1. Patients on combination regimens with these agents are eligible

4) Age >/= 18 years

5) ECOG Performance Status 0-2

6) Adequate organ reserve as follows: 1) Hematologic - WBC >/= 3000/microL, AGC >/= 1500/microL, platelet >/= 100,000/microL; 2) Renal - Creatinine </= 1.5 times upper limit of normal; 3) Hepatic - Bilirubin and transaminases </= 2.5 times upper limit of normal

7) The effects of the three-drug regimen on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

8) Negative qualitative B-HCG (pregnancy test)

9) Signed informed consent

Exclusion Criteria:1) Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 – such as cisplatin, streptozotocin, dacarbazine, carmustine, hexamethylmelamine, mechlorethamine, procarbazine) during the study period

2) Scheduled to receive moderately emetogenic chemotherapy (Hesketh Level 3-4) after Day 1 of the study period

3) Experienced nausea and/or vomiting with prior administration of chemotherapy

4) Prior moderately or highly emetogenic chemotherapy: Patients may have previously received a mildly emetogenic agent (such as a taxane) if no nausea/vomiting was experienced with that chemotherapy

5) Scheduled to receive cranial, abdominal, or pelvic radiation therapy during the study period

6) Treatment with any investigational agent within 30 days of randomization

7) Scheduled to receive treatment during the study period with other potential or known antiemetic agents. Chronically used benzodiazepines may be continued as a single nightly dose for sleep.

8) Scheduled to receive corticosteroid treatment other than the study drug dose during the study period

9) Uncontrolled primary or metastatic CNS tumor (including those with uncontrolled seizures)

10) Other physical causes for nausea or vomiting (such as bowel obstruction) not related to chemotherapy administration

11) Recent history of unexplained nausea or vomiting or history of frequent nausea or vomiting

12) Active bacterial or fungal infection for which administration of a corticosteroid would be contraindicated

13) Hypersensitivity to any of the study agents

14) Sensitivity to sesame oil

15) Planned simultaneous administration of any other investigational agents

16) Pregnant or nursing women

17) Previous poor tolerance of cannabinoids

18) Habitual cannabinoid use or unwillingness to avoid the use of marijuana during the study period

19) Previous use of dronabinol or nabilone

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Links
Registration Number: NCT00553059
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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