Estudio en fase III, abierto y multicéntrico de ABI-007 frente a dacarbazina en pacientes con melanoma maligno metastásico no tratados previamente.An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients with Metastatic Malignant Melanoma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 514

Inclusion Criteria

1. Histologically or cytologically confirmed malignant melanoma with evidence of metastasis (Stage IV).
2. No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Priortreatment with kinase inhibitors or cytokines is permitted. No prior adjuvant cytotoxicchemotherapy is permitted. Prior adjuvant therapy with interferon, GM-CSF and/orvaccines is permitted.
3. Male or non-pregnant and non-lactating female, and ? 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (ß-hCG) within 72 hours prior to first study drug administration. If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
4. No other current active malignancy within the past 3 years.
5. Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion).
6. Patient has the following blood counts at Baseline:
- ANC ? 1.5 x 109 cells/L;
- platelets ? 100 x 109 cells/L;
- Hgb ? 9 g/dL.
7. Patient has the following blood chemistry levels at Baseline:
- AST (SGOT), ALT (SGPT) ? 2.5x upper limit of normal range (ULN); ? 5.0 xULN if hepatic metastases present;
- total bilirubin ? ULN;
- creatinine ? 1.5 mg/dL.
- LDH ? 2.0 x ULNa
8. Expected survival of > 12 weeks.
9. ECOG performance status 0-1.
10. Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of or current evidence of brain metastases, including leptomeningeal involvement.
2. Patient has pre-existing peripheral neuropathy of NCI CTCAE Scale of Grade ? 2.
3. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
4. Patient has a clinically significant concurrent illness.
5. Patient is, in the investigator?s opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
6. Patient is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. Marker studies or studies evaluating biological correlates are permitted.
7. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare the following regimens with respect to antitumor activity in patients who are previously untreated with cytotoxic chemotherapy for metastatic malignant melanoma:<br>? ABI-007 150 mg/m2 Days 1, 8, and 15 every 4 weeks<br>? Dacarbazine 1000 mg/m2 every 3 weeks;Secondary Objective: The secondary objectives of this study are to compare the safety and tolerability of the 2 treatments; and to analyze secreted protein acidic and rich in cysteine (SPARC) and other molecular biomarkers in tumor tissue and peripheral blood and to determine their possible correlation with efficacy outcomes.;Primary end point(s): The primary efficacy endpoint is progression-free survival (PFS) based on a blinded radiology assessment of response using RECIST response guidelines.

Secondary Outcome Measures