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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00553059
First received: November 2, 2007
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants with Total protection [ Time Frame: 5 Days (first 5 days of the first cycle of chemotherapy) ] [ Designated as safety issue: No ]
    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:
  • Acute, Delayed and Overall Total Protection [ Time Frame: Up to 5 days (first 5 days of the first cycle of chemotherapy) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: October 2007
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553059

Locations
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
Solvay Pharmaceuticals
Investigators
Study Chair: Steven M. Grunberg, MD University of Vermont
Study Chair: Amal I. Melhem-Bertrandt, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00553059     History of Changes
Other Study ID Numbers: 2006-0841, MDA-2006-0841, CDR0000573510, NCI-2009-00637
Study First Received: November 2, 2007
Last Updated: February 11, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Tetrahydrocannabinol
BB 1101
Palonosetron
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on July 26, 2014