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Status:

COMPLETED

Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Recurrent Melanoma

Stage IV Melanoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in ...

Detailed Description

OBJECTIVES: Primary I. Determine the anti-tumor activity of carboplatin, paclitaxel, and bevacizumab, in terms of progression-free survival, in patients with unresectable stage IV melanoma. II. Deter...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed melanoma
  • Unresectable stage IV disease
  • Evidence of metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No radiologically confirmed invasion of adjacent organs (e.g., duodenum or stomach)
  • No tumor invasion of major blood vessels
  • No history of primary brain tumor or other CNS disease
  • No brain metastases by MRI or CT scan
  • Performance status - ECOG 0-2
  • More than 4 months
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL (transfusion allowed)
  • No active bleeding
  • Bilirubin ≤ 1.5 mg/dL
  • AST ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • INR ≤ 1.5 times ULN
  • PTT normal
  • No known esophageal varices
  • Creatinine ≤ 1.5 times ULN
  • Urine protein creatinine ratio ≤ 0.5
  • Urine protein \< 1 g/24-hr urine collection
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No myocardial infarction within the past 6 months
  • No unstable angina within the past 6 months
  • No clinically significant peripheral vascular disease
  • No uncontrolled hypertension (i.e., blood pressure ≥ 150/90 mmHg despite antihypertensive therapy)
  • No clinically significant stroke within the past 6 months
  • No deep vein thrombosis within the past year
  • No other vascular abnormality
  • No pulmonary embolus within the past year
  • No history of abdominal fistula
  • No gastrointestinal perforation
  • No intra-abdominal abscess within the past 4 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study therapy
  • No other pathological condition that would confer a high risk of bleeding
  • No active infection requiring parenteral antibiotics
  • No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture
  • No peripheral neuropathy ≥ grade 2
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs
  • No uncontrolled seizures
  • No other uncontrolled illness
  • No significant traumatic injury within the past 4 weeks
  • No prior antivascular endothelial growth factors (VEGF), including any of the following:
  • Bevacizumab
  • VEGF Trap
  • Anti-VEGF receptor monoclonal antibody
  • Small molecular tyrosine kinase inhibitors of VEGF receptors
  • No more than 1 prior systemic chemotherapy regimen
  • No prior carboplatin or paclitaxel
  • No other concurrent chemotherapy
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to \> 25% of bone marrow
  • No concurrent radiotherapy
  • At least 4 weeks since prior major surgical procedure or open biopsy
  • At least 1 week since prior fine-needle aspiration or core biopsy
  • No concurrent major surgery
  • More than 4 weeks since prior systemic therapy
  • No concurrent full-dose oral or parenteral anticoagulation
  • No concurrent antiplatelet therapy except low-dose aspirin (i.e., 81 mg of oral aspirin daily) allowed
  • No other concurrent experimental drugs

Exclusion

    Key Trial Info

    Start Date :

    December 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    47 Patients enrolled

    Trial Details

    Trial ID

    NCT00255762

    Start Date

    December 1 2005

    Last Update

    October 28 2013

    Active Locations (1)

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    North Central Cancer Treatment Group

    Rochester, Minnesota, United States, 55905