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

NCT00553059 | Completed Phase 3 Results DMC

• 4 other identifiers: 2006-0841MDA-2006-0841CDR0000573510NCI-2009-00637
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

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.

Conditions

Chemotherapy-induced Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

nausea and vomiting; unspecified adult solid tumor; Palonosetron; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Total Protection in the Acute, Delayed and Overall Periods

  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.

  5 Days (first 5 days of the first cycle of chemotherapy)

Secondary Outcomes (6)

• Number of Participants With Complete Protection for the Acute, Delayed, and Overall Periods

  Up to 5 days (first 5 days following first cycle of chemotherapy)

• Number of Participants With Complete Response for the Acute, Delayed, and Overall Periods

  Up to 5 days (first 5 days following first cycle of chemotherapy)

• Number of Participants With Vomiting for the Acute, Delayed and Overall Periods

  5 Days (first 5 days of the first cycle of chemotherapy)

• Number of Participants With Nausea for the Acute, Delayed and Overall Periods

  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

  5 Days (first 5 days of the first cycle of chemotherapy)

Study Arms (2)

Arm I: Palonosetron, Dexamethasone + Dronabinol

EXPERIMENTAL

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; Drug: dronabinol; Drug: palonosetron hydrochloride

Arm II: Palonosetron + Dexamethasone

ACTIVE COMPARATOR

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; Drug: palonosetron hydrochloride; Other: placebo

Interventions

dexamethasone DRUG

10 mg IV 30 minutes prior to administration of chemotherapy

Arm I: Palonosetron, Dexamethasone + Dronabinol; Arm II: Palonosetron + Dexamethasone

dronabinol DRUG

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

Arm I: Palonosetron, Dexamethasone + Dronabinol

palonosetron hydrochloride DRUG

0.25 mg IV 30 minutes prior to administration of chemotherapy

Arm I: Palonosetron, Dexamethasone + Dronabinol; Arm II: Palonosetron + Dexamethasone

placebo OTHER

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

Arm II: Palonosetron + Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented solid tumor
• 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
• 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
• Age \>/= 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• 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
• 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.
• Negative qualitative B-human chorionic gonadotropin (HCG) (pregnancy test)
• Signed informed consent

You may not qualify if:

• Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 - such as cisplatin, streptozotocin, dacarbazine, carmustine, hexamethylmelamine, mechlorethamine, procarbazine) during the study period
• Scheduled to receive moderately emetogenic chemotherapy (Hesketh Level 3-4) after Day 1 of the study period
• Experienced nausea and/or vomiting with prior administration of chemotherapy
• 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
• Scheduled to receive cranial, abdominal, or pelvic radiation therapy during the study period
• Treatment with any investigational agent within 30 days of randomization
• 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.
• Scheduled to receive corticosteroid treatment other than the study drug dose during the study period
• Uncontrolled primary or metastatic CNS tumor (including those with uncontrolled seizures)
• Other physical causes for nausea or vomiting (such as bowel obstruction) not related to chemotherapy administration
• Recent history of unexplained nausea or vomiting or history of frequent nausea or vomiting
• Active bacterial or fungal infection for which administration of a corticosteroid would be contraindicated
• Hypersensitivity to any of the study agents
• Sensitivity to sesame oil
• Planned simultaneous administration of any other investigational agents

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Solvay Pharmaceuticals: collaborator

Study Sites (4)

Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

University of Texas M.D. Anderson

Houston, Texas, 77030-4009, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Dexamethasone; Dronabinol; Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Michael J. Fisch, MD/Department of General Oncology
• Organization: University of Texas (UT) MD Anderson Cancer Center

mfisch@mdanderson.org

713-563-9905

Study Officials

• Steven M. Grunberg, MD

  University of Vermont

  STUDY CHAIR

• Amal I. Melhem-Bertrandt, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: May 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-10

Locations

US (4)