Pazopanib Hydrochloride in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7

In brief

This phase II trial is studying the side effects of pazopanib hydrochloride and to see how well it works in treating patients with metastatic melanoma that cannot be removed by surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key facts

Study ID

NCT00861913

Run by

National Cancer Institute (NCI)

People needed

13

Starts

2009-04-03

Expected to finish

2014-01-16

Last updated by the study team

2018-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed unresectable malignant melanoma
• Radiographic or clinical evidence of metastatic disease
• Measurable disease with ≥ 1 lesion whose longest diameter can be measured as ≥ 2.0 cm by CT or MRI scans or ≥ 1.0 cm by spiral CT scan
• Disease that is measurable by physical examination only is not allowed
• No known intraluminal metastatic lesion(s) with suspected bleeding
• No brain metastases by MRI or CT scan
• ECOG performance status 0-2
• Life expectancy > 12 weeks
• WBC ≥ 3,000/μL
• Hemoglobin ≥ 9 g/dL
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Serum troponin normal
• Urine protein ≤ 1+ (≤ 30 mg/dL) on 2 consecutive dipstick or other urine assessments taken ≥ 1 week apart
• QTc interval < 480 msec
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No significant ECG abnormalities (e.g., frequent ventricular ectopy, evidence of ongoing myocardial ischemia)
• No serious nonhealing wound, ulcer, or bone fracture
• No history of abdominal fistula, gastrointestinal perforation, active diverticulitis, intra-abdominal abscess, or gastrointestinal tract bleeding within the past 28 days
• No history of myocardial infarction, cardiac arrhythmia within the past 6 months

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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