A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: ABI-007; Dacarbazine
Intervention description: Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.; Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.
Intervention MeSH terms: Albumin-Bound Paclitaxel; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 529.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; Malignant; Abraxane; ABI-007; Dacarbazine; Dtic-Dome

Summary:

      The main purpose of this research study is to compare the safety, tolerability, and anti
      tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with
      metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new
      preparation of the active drug paclitaxel. It contains the same medication as the
      prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment
      of metastatic breast cancer after failure of combination chemotherapy for metastatic disease
      or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for
      the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy
      for people who have not yet had any cancer treatment for the diagnosis of metastatic
      melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed cutaneous malignant melanoma with evidence
             of metastasis (Stage IV).

          -  No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Prior
             treatment with kinase inhibitors or cytokines is permitted.

          -  No prior adjuvant cytotoxic chemotherapy is permitted. Prior adjuvant therapy with
             interferon, Granulocyte-macrophage colony-stimulating factor (GM-CSF) and/or vaccines
             is permitted.

          -  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 Beta human chorionic gonadotropin (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.

          -  No other current active malignancy within the past 3 years.

          -  Radiographically-documented measurable disease (defined by the presence of at least 1
             radiographically documented measurable lesion

          -  Patient has the following blood counts at Baseline:

          -  Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells/L;

          -  platelets ≥ 100 x 10^9 cells/L;

          -  Hemoglobin (Hgb) ≥ 9 g/dL.

          -  Patient has the following blood chemistry levels at Baseline:

          -  Aspartate aminotransferase(AST) glutamic-oxaloacetic transaminase (SGOT), alanine
             aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5x upper limit
             of normal range (ULN); ≤ 5.0 xULN if hepatic metastases present;

          -  total bilirubin ≤ ULN;

          -  creatinine ≤ 1.5 mg/dL.

          -  Lactate Dehydrogenase (LDH) ≤ 2.0 x ULNa

          -  Expected survival of > 12 weeks.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

          -  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.

        Exclusion Criteria:

          -  History of or current evidence of brain metastases, including leptomeningeal
             involvement.

          -  Patient has pre-existing peripheral neuropathy of National Cancer Institute Common
             Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.

          -  Prior radiation to a target lesion is permitted only if there has been clear
             progression of the lesion since radiation was completed.

          -  Patient has a clinically significant concurrent illness.

          -  Patient is, in the investigator's opinion, unlikely to be able to complete the study
             through the End of Study (EOS) visit.

          -  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.

          -  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.