A Multicenter, Open-Label, Single-Arm Evaluation of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01054456
First received: January 20, 2010
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

This study is designed to assess the safety and efficacy of palonesetron in preventing CINV (Chemotherapy-Induced Nausea and Vomiting) when administered to patients who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.


Condition Intervention Phase
Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC
Drug: palonesetron
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multicenter, Open-Label, Single-Arm Evaluation of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Complete Response rate (defined as no emetic episodes and no rescue medication) [ Time Frame: For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete Response [ Time Frame: At each 24 hour interval (Days 2 through 6) ] [ Designated as safety issue: Yes ]
  • Complete Response [ Time Frame: During 0 to 48, 0 to 72, and 0 to 96 hour time periods; Number of emetic episodes; Severity of nausea ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: palonesetron
One dose administered intravenously 30 minutes pre-chemotherapy
Other Name: palonesetron

Detailed Description:

Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting associated with initial and repeat chemotherapy induced nausea and vomiting (CINV) caused by moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and efficacy of palonesetron in preventing CINV (Chemotherapy-Induced Nausea and Vomiting) when administered to patients who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.

Palonosetron will be given intravenously approximately 30 minutes prior to the start of the chemotherapy regimen. Efficacy and safety including episodes of nausea, retching and or vomiting will be assessed over five 24 hour periods starting on Day 1 and ending on Day 6 in patient diaries. On Day 2 and Day 6 a FLIE (Functional Living Index- Emesis) assessment will also be completed in order to help evaluate the patient's quality of life from the start of the chemotherapy cycle through Day 6.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

In order to be eligible for enrollment, subjects must meet the following inclusion criteria:

  1. Provide written informed consent
  2. Male or female ≥18 years of age
  3. Histologically or cytologically confirmed malignant disease
  4. Karnofsky Index of 50%
  5. Experienced either vomiting and/or at least moderate nausea during their last cycle of LEC
  6. Scheduled to receive, on Study Day 1, a single dose of one of the qualifying LEC agents listed in the protocol.
  7. Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the Investigator Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

  1. Inability or unwillingness to understand or cooperate with the study procedures as determined by the Investigator
  2. Women who are pregnant, nursing or planning to become pregnant, women of childbearing potential who are not using an effective method of pregnancy prevention (including implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence), or women who have had a positive serum pregnancy test at screening or within 7 days prior to receiving chemo on Day 1. Non-childbearing potential includes women who are post-menopausal (12 months of amenorrhea with no other demonstrable cause, in the appropriate age group) or documented surgical sterilization, or hysterectomy at least 3 months before study start.
  3. Previous use of palonosetron in association with a LEC regimen
  4. Received more than one antiemetic agent for prevention of CINV (Chemotherapy-Induced Nausea and Vomiting) during their last cycle of LEC (other than dexamethasone or prednisone as outlined in number 7 below). The use of an antiemetic in addition to a corticosteroid during the last cycle of LEC is allowed if the corticosteroid is intended for the prophylactic treatment of taxane-related hypersensitivity or pemetrexed-related skin reactions as long as the corticosteroid regimen remains unchanged during the trial
  5. Suspected or confirmed ongoing vomiting for any organic etiology (e.g., food poisoning, gastroenteritis, etc)
  6. Received any drug with potential anti-emetic effect within 24 hours prior to the start of qualifying LEC agent
  7. Scheduled to receive an antiemetic (with the exception of administration of the palonosetron) at any time during the trial, listed below

    -5-HT3 receptor antagonists

    • NK1 receptor antagonists
    • Dopamine receptor antagonists (metoclopramide)
    • Phenothiazine anti-emetics (prochlorperazine, promethazine, thiethylperazine and perphenazine)
    • Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide. Diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes (e.g., paclitaxel, docetaxel) and ixabepilone
    • All benzodiazepines except Triazolam or Zolpidem used once at night time due to sleep disturbances
    • Atypical antipsychotic agents with compazine-like activity (e.g., olanzapine, risperidone)
    • Butyrophenones (haloperidol, droperidol)
    • Cannabinoides (tetrahydrocannabinol or nabilone)
    • Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone), with the exception of topical or inhaled preparations. Dexamethasone will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes (e.g., paclitaxel, docetaxel) or prevention of rash associated with pemetrexed. Prednisone will be allowed if given for as part of standard regimen with mitoxantrone or docetaxel for prostate cancer.
    • Any non-prescription medication, nutritional supplements, vitamins or herbal-type products known to either possibly cause nausea or vomiting, or used to treat nausea or vomiting
  8. Having received any investigational drugs or devices within 30 days before study entry
  9. Any vomiting, retching, or National Cancer Institute Common Terminology Criteria for Adverse Events, v.3 (NCI CTCAE) Grade 2 to 4 nausea in the 24 hours preceding chemotherapy
  10. History of alcohol or drug abuse
  11. Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in this protocol
  12. Any known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients
  13. Scheduled to receive or have received radiotherapy within 1 week prior to or during the study
  14. Any condition that, in the judgment of the Principal Investigator, would make a subject ineligible for participation in the study
  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: NCT01054456

Locations
United States, Florida
Sheridan Clinical Research
Sunrise, Florida, United States, 33323
United States, Illinois
Medical and Surgical Specialists
Galesburg, Illinois, United States, 61401
Orchard Healthcare Research Inc
Skokie, Illinois, United States, 60076
United States, Kentucky
Trover Center for Clinical Studies; Merle Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
United States, New York
Hematology- Oncology Associates of Rockland, PC
Nyack, New York, United States, 10960
United States, Ohio
Signal Point Clinical Research
Middletown, Ohio, United States, 45042
United States, Texas
Scott and White Clinic- College Station
College Station, Texas, United States, 77840
Scott and White Healthcare- Round Rock
Round Rock, Texas, United States, 76559
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Raza Ahmed Eisai Inc.
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunita Hack, Eisai inc.
ClinicalTrials.gov Identifier: NCT01054456     History of Changes
Other Study ID Numbers: PALO-08-13
Study First Received: January 20, 2010
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
LEC
Low Emetogenic Chemotherapy
Nausea and Vomiting
Nausea
Vomiting
Anti- emetic

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Emetics
Palonosetron
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014