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Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
This study is ongoing, but not recruiting participants.
First Received: November 18, 2005   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00255762
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells.

PURPOSE: 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.


Condition Intervention Phase
Melanoma (Skin)
Biological: bevacizumab
Drug: carboplatin
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Carboplatin, Weekly Paclitaxel and Biweekly Bevacizumab in Patients With Unresectable Stage IV Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 8-week progression free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confirmed tumor response (complete response or partial response) [ Designated as safety issue: No ]
  • Clinical response rate [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: December 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the anti-tumor activity of carboplatin, paclitaxel, and bevacizumab, in terms of progression-free survival, in patients with unresectable stage IV melanoma.
  • Determine the toxicity profile of this regimen in these patients.

Secondary

  • Determine the distribution of overall survival times in patients treated with this regimen.
  • Determine the response rate in patients treated with this regimen.
  • Determine the changes in blood levels of vascular endothelial growth factor in patients treated with this regimen.
  • Determine the changes in immune homeostasis in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • More than 4 months

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (transfusion allowed)
  • No active bleeding

Hepatic

  • 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

Renal

  • Creatinine ≤ 1.5 times ULN
  • Urine protein creatinine ratio ≤ 0.5 OR
  • Urine protein < 1 g/24-hr urine collection

Cardiovascular

  • 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 mm Hg despite antihypertensive therapy)
  • No clinically significant stroke within the past 6 months
  • No deep vein thrombosis within the past year
  • No other vascular abnormality

Pulmonary

  • No pulmonary embolus within the past year

Gastrointestinal

  • No history of abdominal fistula
  • No gastrointestinal perforation
  • No intra-abdominal abscess within the past 4 weeks

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • 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

Chemotherapy

  • No more than 1 prior systemic chemotherapy regimen
  • No prior carboplatin or paclitaxel
  • No other concurrent chemotherapy

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to > 25% of bone marrow
  • No concurrent radiotherapy

Surgery

  • 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

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255762

  Show 98 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Svetomir Markovic, MD, PhD Mayo Clinic
Investigator: Daniel Nikcevich, MD, PhD Duluth Clinic Cancer Center - Duluth
Investigator: Edward T. Creagan, MD Mayo Clinic
Investigator: Lori A. Erickson, MD Mayo Clinic
Investigator: Judith S. Kaur, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Perez DG, Suman VJ, Fitch TR, Amatruda T 3rd, Morton RF, Jilani SZ, Constantinou CL, Egner JR, Kottschade LA, Markovic SN. Phase 2 trial of carboplatin, weekly paclitaxel, and biweekly bevacizumab in patients with unresectable stage IV melanoma: a North Central Cancer Treatment Group study, N047A. Cancer. 2009 Jan 1;115(1):119-27.
Perez DG, Suman V, Amatruda T, et al.: Phase II trial of carboplatin, weekly paclitaxel, and biweekly bevacizumab in patients with unresectable stage IV melanoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-8560, 487s, 2007.

Study ID Numbers: CDR0000449967, NCCTG-N047A
Study First Received: November 18, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00255762     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Study placed in the following topic categories:
Bevacizumab
Carboplatin
Antimitotic Agents
Angiogenesis Inhibitors
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Paclitaxel
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Tubulin Modulators
Neuroepithelioma
Nevus
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Neoplasms, Nerve Tissue
Antimitotic Agents
Bevacizumab
Carboplatin
Angiogenesis Inhibitors
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Paclitaxel
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Tubulin Modulators
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 02, 2009