Clinical Study of Previously Untreated Patients With Malignant Melanoma

Launched by CLAVIS PHARMA · Oct 4, 2005

Keywords

ClinConnect Summary

This is an international multicentre phase II clinical study conducted in the USA and Europe. Previously untreated patients over 18 years, with metastatic malignant melanoma are eligible for inclusion if they fulfil all inclusion- and exclusion criteria. 16 or 42 patients will be enrolled in Pittsburgh USA, Lund Sweden and Oslo Norway.

The new development drug CP-4055 is administered for five consecutive days (Day 1 to 5) in a 4 week schedule (one cycle). The dose is 200 mg/m2/day.

A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Stud...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy for the treatment of melanoma (chemotherapy-naïve)
• • Measurable disease according to Response Criteria in Solid Tumours (RECIST)
• • Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
• • Age 18 years or more
• • Life expectancy \> 3 months
• • Signed informed consent
• * Adequate haematological and biological functions:
• * Bone marrow function:
• • 1. Neutrophils ≥ 1.5 x 10\^9/L
• • 2. Platelets ≥ 100 x 10\^9/L
• • 3. Hemoglobin (Hb) ≥ 10 g/dL
• * Hepatic function:
• • 1. AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN.
• • 2. Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN
• * Renal function:
• • Creatinine ≤ 1.5 times institutional ULN
• Exclusion Criteria:
• • Known brain metastases
• • Diagnosis of ocular malignant melanoma
• • Radiotherapy to more than 30% of bone marrow
• • Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
• • Prior immunotherapy and/or chemotherapy for the treatment of melanoma
• * Requirement of concomitant treatment with a non-permitted medication:
• • Alternative drugs
• • High doses of vitamins
• • History of allergic reactions to Ara-C or egg
• • Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled intercurrent illness including ongoing or active infection)
• • Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
• • Pregnancy, breastfeeding, or absence of adequate contraception for both male and female fertile patients
• • Known positive status for HIV and/or hepatitis B or C
• • Drug and/or alcohol abuse
• • Any reason why, in the Investigator's opinion, the patient should not participate