Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

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. Identifier: NCT00412425
Recruitment Status : Completed
First Posted : December 18, 2006
Results First Posted : May 4, 2012
Last Update Posted : May 4, 2012
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Primary Objectives:

  • Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy.
  • To determine the patterns and severity of nausea and vomiting in two groups of patients with metastatic melanoma receiving biochemotherapy with palonosetron premedication using two schedules of palonosetron administration.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Palonosetron Phase 1 Phase 2

Detailed Description:

Palonosetron is designed to work by blocking the substance serotonin from binding to the brain and gastrointestinal tract, which may help to decrease nausea and vomiting.

Participants in this study will be receiving biochemotherapy treatment as part of their routine care. This treatment will include 3 chemotherapy drugs (cisplatin, vinblastine, and DTIC) and 2 drugs that stimulate the immune system (interferon and interleukin-2 (IL-2)). Biochemotherapy often causes nausea, vomiting, loss of appetite, and weight loss. Palonosetron will be given on this study to try to treat the side effects of biochemotherapy.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. You have an equal chance of being assigned to either group.

Participants in Group 1 will receive palonosetron by vein over a few minutes starting 30 minutes before receiving chemotherapy on Days 1 and 4 of therapy. Participants in Group 2 will receive palonosetron by vein over a few minutes on Days 1, 3, and 5.

All participants on this study will also receive Ativan by vein every 8 hours for 5 days. Ativan is given for additional control of nausea and it will also help to sedate you. In addition to palonosetron, you may be given standard anti-nausea medications such as lorazepam or compazine if you experience intolerable nausea and vomiting while on study.

You will also be asked to fill out a Functional Living Index-Emesis (FLIE) questionnaire every day for 7 days in a row. The questionnaire will ask about any nausea and/or vomiting you are experiencing and the effect of the therapy on your quality of life. You will stay in the hospital for at least 7 days while you receive treatment.

After the first course of palonosetron given with biochemotherapy, your doctor will decide if you will receive additional courses of palonosetron or if you will be given another anti-nausea drug.

If your doctor does decide to have you continue on palonosetron, it will be given off study. Your participation in this study will be over after 1 course.

This is an investigational study. Palonosetron has been approved by FDA for control of nausea and vomiting caused by chemotherapy. However, it has not been adequately evaluated for safety and effectiveness in patients receiving high dose interleukin-2 alone or in combination with chemotherapy. About 30 patients will take part in this study. All patients will enrolled at M. D. Anderson.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Two Different Schedules of Palonosetron for the Prevention of Nausea and Vomiting in Patients With Metastatic Melanoma Receiving Concurrent Biochemotherapy
Study Start Date : November 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 2 Days Palonosetron
2 Days Palonosetron 0.25 mg intravenous (IV)
Drug: Palonosetron
0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.

Active Comparator: 3 Days Palonosetron
3 Days Palonosetron 0.25 mg IV
Drug: Palonosetron
0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.

Primary Outcome Measures :
  1. Cumulative Participants Response to Palonosetron [ Time Frame: 7 days ]
    Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • They have non-resectable stage III or IV metastatic melanoma with measurable disease and have agreed to be treated with biochemotherapy.
  • They have Zubrod performance status of 0-1
  • They have normal blood counts with a white blood count (WBC) count >/= 3,500/mm^3, ANC >/= 1,500/mm^3 and a platelet count >/= 100,000/mm^3 and have serum creatinine <1.5 mg/dl, and serum bilirubin level < 1.5 mg/dl, and no evidence of significant cardiac or pulmonary dysfunction.
  • They have no significant intercurrent illness such as a serious infection, significant psychiatric illness, hypercalcemia (calcium >11 mg), gastro-intestinal (GI) bleeding or evidence of brain metastasis.
  • They have not been exposed to prior interferon, interleukin-2 or previous chemotherapy including regional perfusion. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
  • They must have been off corticosteroids for at least 2 weeks.

Exclusion Criteria:

  • They are younger than 18 years or more than 65 years of age and those with an expected survival of less than 8 weeks or a Zubrod performance status of 2, 3 or 4.
  • They have received previous treatment with any prior systemic chemotherapy for unresectable metastasis including and not limited to the following drugs: cisplatin, vinblastine, Dacarbazine (DTIC), interferon and interleukin-2
  • They have active central nervous system involvement by melanoma either as brain metastasis, spinal cord compression, or meningeal carcinomatosis".
  • They have significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricular function or serious cardiac arrhythmias requiring therapy.
  • They have significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD).
  • They have symptomatic effusions on account of pleural, pericardial or peritoneal metastasis of melanoma.
  • They have history of a second malignant tumor (except for other skin cancers and in situ carcinoma of the cervix) within the past 5 years and uncertainty about the histologic nature of the metastatic lesions.
  • They are on corticosteroids or any other type of immunosuppressive agent (e.g., methotrexate, chloroquine, azathioprine, cyclophosphamide).
  • They are pregnant or breast feeding. Patients of childbearing potential must agree to use an effective method of contraception.
  • They have known hypersensitivity to any of the study drugs or to other selective 5-HT3(subscript).
  • They have ongoing emesis due to any organic etiology including but not limited to central nervous system or gastrointestinal metastasis.
  • They have grade 2 or higher nausea due to administration of drugs including but not limited to narcotics.

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 identifier (NCT number): NCT00412425

United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Principal Investigator: Agop Y. Bedikian, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00412425     History of Changes
Other Study ID Numbers: 2005-0506
First Posted: December 18, 2006    Key Record Dates
Results First Posted: May 4, 2012
Last Update Posted: May 4, 2012
Last Verified: April 2012

Keywords provided by M.D. Anderson Cancer Center:
Loss of Appetite
Weight loss

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Signs and Symptoms, Digestive
Signs and Symptoms
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs