Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery

NHS Foundation Trust

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Drug: vatalanib

Study type: Interventional

Funder types: Other

Identifiers

NCT00563823

EU-20787

EUDRACT-2005-004710-33

CDR0000576458 (Registry Identifier)

CRCA-CCTC-CAMEL02

CCLG-Camel-02

ISRCTN00191981 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Vatalanib 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.

PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.

Full description

OBJECTIVES:

Primary

• To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib.

Secondary

• To determine the time to progression in these patients.
• To determine the 6-month and 1-year survival of these patients.
• To determine the overall survival of these patients.
• To determine the safety and toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

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

After completion of study therapy, patients are followed at 8 weeks and then periodically thereafter.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic cutaneous melanoma

  • Unresectable disease

• Measurable disease, defined as ≥ 1 bidimensionally measurable lesion by clinical or radiological techniques (i.e., chest x-ray, CT scan, or conventional MRI scan) using RECIST criteria

• No history or presence of CNS disease (i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases, or carcinomatous meningitis)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• Hemoglobin ≥ 10 g/dL

• Platelet count ≥ 100,000/mm^3

• WBC ≥ 3,000/mm^3

• ANC ≥ 1,500/mm^3

• Bilirubin ≤ 1.5 x upper limit of normal (ULN)

• Alkaline phosphatase ≤ 3 x ULN (≤ 5 if liver metastases are present)

• Transaminases ≤ 3 x ULN (≤ 5 if liver metastases are present)

• Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min

• Total urinary protein ≤ 500 mg by 24-hour urine collection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• No history of other malignant disease except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No other serious or uncontrolled illness which, in the opinion of the investigator, precludes study entry

• No medical or psychiatric condition that precludes giving informed consent

• No history of renal disease (e.g., glomerulonephritis) or renal vascular disease

• No acute or chronic active liver disease (e.g., hepatitis or cirrhosis)

• No concurrent severe and/or uncontrolled medical conditions that would compromise participation in the study, including any of the following:

  • Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
  • Unstable angina pectoris
  • Symptomatic congestive heart failure
  • Myocardial infarction within the past 6 months
  • Serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes
  • Active or uncontrolled infection

• No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib including, but not limited to, any of the following conditions:

  • Ulcerative disease
  • Uncontrolled nausea
  • Vomiting
  • Diarrhea which might result in malabsorption
  • Any known malabsorption syndrome
  • Bowel obstruction
  • Inability to swallow the capsules/tablets

PRIOR CONCURRENT THERAPY:

• Recovered from all prior therapy

• Prior adjuvant therapy allowed

• Prior radiotherapy allowed

  • Measurable target lesions must not have been irradiated

• No more than one line of prior systemic therapy for advanced melanoma

• More than 4 weeks since prior chemotherapy, immunotherapy, or investigational agent

• More than 2 weeks since prior surgery

• No concurrent warfarin or other similar oral anticoagulants that are metabolized by the cytochrome p450 system

  • Concurrent heparin allowed

• Concurrent radiotherapy for symptomatic disease is allowed, provided the lesions being irradiated contribute ≤ 20% of the sum of the longest diameter for all target lesions being used to determine response