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Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer

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ClinicalTrials.gov Identifier: NCT00553059
Recruitment Status : Completed
First Posted : November 5, 2007
Last Update Posted : September 5, 2014
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Solvay Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific Drug: dexamethasone Drug: dronabinol Drug: palonosetron hydrochloride Other: placebo Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official 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
Study Start Date : May 2008
Actual Primary Completion Date : August 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I: Palonosetron, Dexamethasone + Dronabinol
Palonosetron hydrochloride intravenous (IV) and dexamethasone IV 30 minutes before chemotherapy administration on day 1, and oral dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy administration on day 1.
 Drug: dexamethasone
10 mg IV 30 minutes prior to administration of chemotherapy

Drug: dronabinol
5 mg tablet by mouth three times a day beginning 30 minutes before chemotherapy

Drug: palonosetron hydrochloride
0.25 mg IV 30 minutes prior to administration of chemotherapy
Active Comparator: Arm II: Palonosetron + Dexamethasone
Palonosetron hydrochloride and dexamethasone as in arm I, and oral placebo 3 times a day for 5 days beginning 30 minutes before chemotherapy on day 1.
 Drug: dexamethasone
10 mg IV 30 minutes prior to administration of chemotherapy

Drug: palonosetron hydrochloride
0.25 mg IV 30 minutes prior to administration of chemotherapy

Other: placebo
1 tablet by mouth three times a day beginning 30 minutes before chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Total protection [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
    Total protection is defined as no vomiting, no rescue therapy, and no nausea as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire during the overall [0-120 hour] period.


Secondary Outcome Measures :
  1. Acute, Delayed and Overall Total Protection [ Time Frame: Up to 5 days (first 5 days of the first cycle of chemotherapy) ]
    Total protection is defined as no vomiting, no rescue therapy, and no nausea evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire.

  2. Complete response and Complete Protection for the acute, delayed, and overall periods [ Time Frame: Up to 5 days (first 5 days following first cycle of chemotherapy) ]
    Complete response is defined as vomiting episodes with rescue medication, and Complete Protection is no vomiting, no rescue therapy, and no nausea evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  6. Adequate organ reserve as follows: 1) Hematologic - white blood cell count (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-human chorionic gonadotropin (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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553059


Locations
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United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Texas
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States, 77030-4009
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Solvay Pharmaceuticals
Investigators
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Study Chair: Steven M. Grunberg, MD University of Vermont
Study Chair: Amal I. Melhem-Bertrandt, MD M.D. Anderson Cancer Center
More Information
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Additional Information:
University of Texas MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00553059     History of Changes
Other Study ID Numbers: 2006-0841
MDA-2006-0841
CDR0000573510 ( Other Identifier: NCI )
NCI-2009-00637 ( Registry Identifier: NCI CTRP )
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by M.D. Anderson Cancer Center:
nausea and vomiting
unspecified adult solid tumor
Palonosetron
Dexamethasone

Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Palonosetron
Dronabinol
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic