Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

NCT00412425 | Completed Phase 1 Results

• 1 other identifier: 2005-0506
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Melanoma; Nausea; Vomiting; Palonosetron; Cisplatin; Vinblastine; Loss of Appetite; Weight loss

Outcome Measures

Primary Outcomes (1)

• Cumulative Participants Response to Palonosetron

  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.

  7 days

Study Arms (2)

2 Days Palonosetron

ACTIVE COMPARATOR

2 Days Palonosetron 0.25 mg intravenous (IV)

Drug: Palonosetron

3 Days Palonosetron

ACTIVE COMPARATOR

3 Days Palonosetron 0.25 mg IV

Drug: Palonosetron

Interventions

Palonosetron DRUG

0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.

2 Days Palonosetron; 3 Days Palonosetron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eisai Inc.: collaborator

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Melanoma; Nausea; Vomiting; Anorexia; Weight Loss

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Agop Bedikian, MD Professor
• Organization: UT MD Anderson Cancer Center

asreckew@mdanderson.org

Study Officials

• Agop Y. Bedikian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 18, 2006
• Study Start: November 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 4, 2012
• Results First Posted: May 4, 2012

Record last verified: 2012-04

Locations

US (1)