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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00093119
First received: October 1, 2004
Last updated: June 11, 2009
Last verified: January 2006
  Purpose

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.


Condition Intervention Phase
Melanoma
Metastases
Drug: ABI-007
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.

Secondary Outcome Measures:
  • Evaluate number of cycles required before patients achieve maximum response

Estimated Enrollment: 33
Study Start Date: January 2004
  Eligibility

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

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
  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: NCT00093119

Locations
United States, North Carolina
Abraxis BioScience Inc.
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Michael Hawkins Celgene Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00093119     History of Changes
Other Study ID Numbers: CA014-0
Study First Received: October 1, 2004
Last Updated: June 11, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Metastatic 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
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014