Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery

NCT01533948 | Terminated Phase 2 Results DMC

• 3 other identifiers: I 197811NCI-2011-03037P30CA016056
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well axitinib works in treating patients with melanoma that has spread to other places in the body or cannot be removed by surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Extraocular Extension Melanoma; Metastatic Intraocular Melanoma; Recurrent Intraocular Melanoma; Recurrent Melanoma; Stage IIIA Intraocular Melanoma; Stage IIIA Melanoma; Stage IIIB Intraocular Melanoma; Stage IIIB Melanoma; Stage IIIC Intraocular Melanoma; Stage IIIC Melanoma; Stage IV Intraocular Melanoma; Stage IV Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Up to 30 days

Secondary Outcomes (4)

• Number of Patients That Experienced at Least One Grade 3 Adverse Event

  Up to 30 days

• Median Progression-free Survival (PFS)

  From the date of study enrollment to the first observation of progressive disease or death within 30 days after last dose of study drug

• Median Overall Survival (OS)

  From the date of study enrollment to the time of death within 30 days after last dose of study drug

• The Baseline Circulative Tumor Cells Value of Responders

  Baseline

Study Arms (1)

Treatment (axitinib)

EXPERIMENTAL

Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: axitinib; Other: laboratory biomarker analysis

Interventions

axitinib DRUG

Given PO

Also known as: AG-013736, Inlyta

Treatment (axitinib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (axitinib)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically proven melanoma (including uveal) that is advanced (metastatic) or unresectable
• Measurable disease
• No more than two prior regimens (0-2) of systemic therapy for metastatic or recurrent disease; therapy (systemic or radiotherapy) administered in the neo-adjuvant or adjuvant setting for previously localized disease is permitted, provided it was completed more than 3 months prior to enrollment; palliative radiotherapy is permitted provided it is completed \>= 2 weeks prior to study therapy initiation and there is at least one measurable lesion outside the radiation field; at least 2 weeks since the end of prior systemic treatment, radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =\< 1 or back to baseline except for alopecia or hypothyroidism
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Life expectancy \>= 12 weeks
• Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3
• Platelets \>= 75,000 cells/mm\^3
• Hemoglobin \>= 9.0 g/dL
• Creatinine =\< 1.5 X upper limit normal (ULN) or calculated creatinine clearance \>= 60 mL/min
• Bilirubin =\< 1.5 X ULN
• Transaminase =\< 2.5 X ULN (for documented liver metastases, transaminase up to 5 X ULN is permitted)
• Random urinary protein/creatinine ratio \< 2
• Have the ability to swallow and retain oral medication
• No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart; the baseline systolic blood pressure readings must be =\< 140 mm Hg, and the baseline diastolic blood pressure readings must be =\< 90 mm Hg; patients whose hypertension is controlled by antihypertensive therapies are eligible
• Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment

You may not qualify if:

• Prior anti-angiogenic therapy
• Major surgery \< 4 weeks or radiation therapy \< 2 weeks of starting the study treatment; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least 1 measurable lesion that has not been irradiated
• Significant history of bleeding events (e.g., hemoptysis, grade 3 or grade 4 gross hematuria) within 6 months prior to registration
• Presence of serious non-healing wounds, ulcers (including gastro-intestinal) and bone fractures
• Gastrointestinal abnormalities including:
• Inability to take oral medication
• Requirement for intravenous alimentation
• Prior surgical procedures affecting absorption including total gastric resection; segmental small bowel or colon resection is permitted
• Treatment for active peptic ulcer disease in the past 6 months
• Active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 6 months without evidence of resolution documented by endoscopy or colonoscopy
• Malabsorption syndromes
• History of gastrointestinal (GI) perforation within prior 12 months
• Current use or anticipated need for treatment with drugs that are known potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine)
• Current use or anticipated need for treatment with drugs that are known CYP3A4 or cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort)
• Requirement of therapeutic anticoagulant therapy with oral vitamin K antagonists; low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed; therapeutic use of low molecular weight heparin (or similar parenteral drug) for venous-thromboembolic disease is allowed

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Matuesz Opyrchal, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: February 16, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 9, 2018
• Results First Posted: May 9, 2018

Record last verified: 2018-05

Locations

US (1)