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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093119
• Other study ID #: CA014
• Status: Completed
• Phase: Phase 2
• First received: October 1, 2004
• Last updated: April 25, 2017
• Start date: July 2003

Study information

• Verified date: April 2017
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastases

Intervention

Drug:
• ABI-007

Locations

Country	Name	City	State
United States	Abraxis BioScience Inc.	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
Secondary	Evaluate number of cycles required before patients achieve maximum response