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

NCT00093119 | Completed Phase 2

• 1 other identifier: CA014
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma; Metastases

Keywords

Metastatic Melanoma

Outcome Measures

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

Interventions

ABI-007 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Abraxis BioScience Inc.

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Hawkins

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2004
• First Posted: October 4, 2004
• Study Start: July 1, 2003
• Primary Completion: February 1, 2005
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

US (1)