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Completed

NCT Number: NCT00093119

Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.

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Key information

Conditions

Melanoma Metastases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Abraxis BioScience Inc.

Durham, North Carolina, 27703, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed Metastatic Melanoma
  • At least 18 years old
  • No other active malignancy
  • Hemoglobin at least 9
  • Platelet Count at least 100,000 cells/mm3
  • ANC at least 1500 cells/mm3
  • AST & ALT less than 2.5X upper limit of normal
  • Total bilirubin less than 1.5mg/dL
  • Creatine less than 1.5 mg/dL
  • Alkaline phosphatase less than 2.5X upper limit of normal
  • Life expectancy of at least 12 weeks
  • ECOG performance status of 0-1
  • Patient must provide informed consent
  • Patient must provide authorization to disclose

Exclusion criteria

  • Evidence of active brain metastases
  • The only evidence of metastasis is lytic or blastic bone metastases
  • Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2
  • Received radiotherapy in last 4wks, except if to a non-target lesion only
  • Clinically significant concurrent illness
  • Investigator's opinion that patient unlikely to complete study
  • Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks
  • History of allergy/hypersensitivity to study drug
  • Serious Medical Risk Factors determine by the investigator

Treatment and study plan

ABI-007

Drug

Primary outcomes

  1. Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.

Secondary outcomes

  1. Evaluate number of cycles required before patients achieve maximum response

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

Important dates

Study start
2003
Primary completion
2005
First posted
Oct 4, 2004
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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