Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00553059
Recruitment Status : Completed
First Posted : November 4, 2007
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Solvay Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Show Show detailed description

Layout table for study information
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
Actual Study Completion Date : August 2014


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




Primary Outcome Measures :
  1. Number of Participants With Total Protection in the Acute, Delayed and Overall Periods [ 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 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. Data to be recorded in the study diary during the 5-day study period. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.


Secondary Outcome Measures :
  1. Number of Participants With Complete Protection for the Acute, Delayed, and Overall Periods [ Time Frame: Up to 5 days (first 5 days following first cycle of chemotherapy) ]
    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. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.

  2. Number of Participants With Complete Response 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 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. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.

  3. Number of Participants With Vomiting for the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
    Number of Participants with Vomiting Acute, Delayed and Overall. 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. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.

  4. Number of Participants With Nausea for the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
    Number of Participants with Nausea for the Acute, Delayed and Overall Periods. 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. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.

  5. Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
    Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods. 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. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.

  6. Number of Participants Received Rescue Medication in the Acute, Delayed and Overall Periods [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ]
    The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present. The first section asks the patient to record presence and severity of nausea during the last 24 hours. The second section asks the patient to record vomiting episodes during the last 24 hours. The third section asks if the patient took medication for nausea or vomiting during the last 24 hours and asks how useful the treatment for nausea or vomiting was. The fourth section screens for toxicity by asking about side effects and problems experienced during the last 24 hours. Use of rescue antiemetic medication and adverse events also assessed and documented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location information
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
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
Layout table for investigator information
Study Chair: Steven M. Grunberg, MD University of Vermont
Study Chair: Amal I. Melhem-Bertrandt, MD M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00553059    
Other Study ID Numbers: 2006-0841
MDA-2006-0841
CDR0000573510 ( Other Identifier: NCI )
NCI-2009-00637 ( Registry Identifier: NCI CTRP )
First Posted: November 4, 2007    Key Record Dates
Results First Posted: October 9, 2020
Last Update Posted: October 9, 2020
Last Verified: October 2020
Keywords provided by M.D. Anderson Cancer Center:
nausea and vomiting
unspecified adult solid tumor
Palonosetron
Dexamethasone
Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Dronabinol
Palonosetron
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
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators