Know Cancer

or
forgot password

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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC

Thank you

Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Complete Response rate (defined as no emetic episodes and no rescue medication)

Outcome Time Frame:

For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall).

Safety Issue:

Yes

Principal Investigator

Raza Ahmed

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

PALO-08-13

NCT ID:

NCT01054456

Start Date:

November 2009

Completion Date:

October 2010

Related Keywords:

  • Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC
  • LEC
  • Low Emetogenic Chemotherapy
  • Nausea and Vomiting
  • Nausea
  • Vomiting
  • Anti- emetic
  • Nausea
  • Vomiting

Name

Location

Scott and White Memorial HospitalTemple, Texas  76508
Medical and Surgical SpecialistsGalesburg, Illinois  61401
Signal Point Clinical ResearchMiddletown, Ohio  45042
Sheridan Clinical ResearchSunrise, Florida  33323
Orchard Healthcare Research IncSkokie, Illinois  60076
Trover Center for Clinical Studies; Merle Mahr Cancer CenterMadisonville, Kentucky  42431
Hematology- Oncology Associates of Rockland, PCNyack, New York  10960
Scott and White Clinic- College StationCollege Station, Texas  77840
Scott and White Healthcare- Round RockRound Rock, Texas  76559