Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Eisai Inc.
• Treatments: Palonosetron

Criteria

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.