Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00404235
First received: November 27, 2006
Last updated: June 17, 2012
Last verified: January 2009
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery.


Condition Intervention Phase
Melanoma (Skin)
Drug: carboplatin
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Genetic: protein expression analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: biopsy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Carboplatin (CBDCA) and ABI-007(ABX) 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:
  • Tumor response as measured by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity profile [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: October 2006
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) in patients with unresectable stage IV melanoma who have not received prior chemotherapy for their metastatic disease. (Cohort 1)
  • Assess the safety and antitumor activity of this regimen in patients with unresectable stage IV melanoma who have received prior chemotherapy for their metastatic disease. (Cohort 2)

Secondary

  • Describe the impact of this regimen on parameters of immune function and angiogenesis in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no).

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 74 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 or cytologically confirmed unresectable stage IV melanoma
  • Measurable disease
  • Must have formalin-fixed, paraffin-embedded tumor tissue available for secreted protein acidic and rich in cysteine (SPARC) analysis pre-treatment (Mayo Clinic patients must be willing to submit a repeat biopsy at time of tumor progression)
  • Brain metastases allowed provided they were previously treated with no progression for ≥ 3 months

    • Patients with known brain metastases may receive concurrent steroid treatment

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (may be transfused to meet this requirement)
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN (elevated bilirubin allowed in patients with documented Gilbert's syndrome)
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after completion of study therapy
  • No uncontrolled intercurrent illness including, but not limited to, the following:

    • Active infection
    • Congestive heart failure (New York Heart Association class III-IV heart disease)
  • No peripheral neuropathy ≥ grade 2
  • No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin previously treated with local resection only or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior interferon or interleukin-2
  • At least 4 weeks since prior chemotherapy (cohort 1 )
  • No prior chemotherapy in the metastatic setting (cohort 2)
  • No prior treatment for melanoma with any of the following agents:

    • Platinum chemotherapy (e.g., carboplatin or cisplatin)
    • Taxanes (e.g., paclitaxel or docetaxel)
    • Paclitaxel albumin-stabilized nanoparticle formulation (ABI-007)
  • No other concurrent chemotherapy
  • No other concurrent investigational agents
  • No concurrent radiotherapy, including palliative radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404235

  Show 156 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Svetomir Markovic, MD, PhD Mayo Clinic
Investigator: Lisa Kottschade, RN, MSN, CNP Mayo Clinic
Investigator: Thomas T. Amatruda, MD Humphrey Cancer Center - Fridley
Investigator: Ravi D. Rao, MD, MBBS Mayo Clinic
Investigator: Judith S. Kaur, MD Mayo Clinic
Investigator: Henry C. Pitot, MD Mayo Clinic
Investigator: Gary A. Croghan, MD, PhD Mayo Clinic
Investigator: Robert McWilliams, MD Mayo Clinic
Investigator: Edward T. Creagan, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Jan C. Buckner, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00404235     History of Changes
Other Study ID Numbers: CDR0000514561, NCCTG-N057E
Study First Received: November 27, 2006
Last Updated: June 17, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014