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

NCT00861913 | Completed Phase 2 Results

• 7 other identifiers: NCI-2009-01163CDR0000637188MAYO-MC0875MC08758218N01CM62205P30CA015083
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Recurrent Melanoma; Stage IV Cutaneous Melanoma AJCC v6 and v7

Outcome Measures

Primary Outcomes (2)

• Tumor Response Rate

  Tumor response rate is defined as the number of eligible patients whose disease status meets the Response Evaluation Criteria In Solid Tumors (RECIST) criteria for compete response (CR) or partial response (PR) divided by the number of evaluable patients. A ninety percent confidence interval for the true response proportion will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution and using the Duffy-Santner approach. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.

  Up to 5 years

• Toxicity

  Toxicity is defined as any grade 3 or higher adverse event as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and at least possibly related to treatment. The maximum grade for each type of toxicity will be recorded for each patient. We report the number of patients experiencing a grade 3 or higher adverse event at least possibly related to treatment.

  Up to 5 years

Secondary Outcomes (3)

• Overall Survival

  From registration to death due to any cause, assessed up to 5 years

• Progression Free Survival

  From registration to documentation of disease progression, assessed up to 5 years

• Duration of Response

  From time of documented response to the date progression is documented, assessed up to 5 years.

Study Arms (1)

Treatment (pazopanib hydrochloride)

EXPERIMENTAL

Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Drug: Pazopanib Hydrochloride; Other: Pharmacological Study

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (pazopanib hydrochloride)

Pazopanib Hydrochloride DRUG

Given orally

Also known as: GW786034B, Votrient

Treatment (pazopanib hydrochloride)

Pharmacological Study OTHER

Correlative studies

Treatment (pazopanib hydrochloride)

Eligibility Criteria

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

pazopanib

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

Results Point of Contact

• Title: Amy M. Weise, D. O.
• Organization: Karmanos Cancer Institute, Wayne State University

313-576-8952

Study Officials

• Amy Weise

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 16, 2009
• Study Start: April 3, 2009
• Primary Completion: September 14, 2010
• Study Completion: January 16, 2014
• Last Updated: October 16, 2018
• Results First Posted: January 21, 2014

Record last verified: 2018-09

Locations

US (4)