Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

Completed · Phase 1/Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00412425

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2006-11-01

Expected to finish

2009-05-01

Last updated by the study team

2012-05-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• U.T. M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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