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

• Sponsor: Celgene (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00093119
• Collaborator: (none)
• Enrollment: 75
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma; Metastases	Drug: ABI-007	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Feb 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Abraxis BioScience Inc.	Durham	North Carolina	United States	27703

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Michael Hawkins, Celgene Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT00093119
• Other Study ID Numbers: CA014
• First Posted: Oct 4, 2004
• Last Update Posted: Apr 26, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Celgene: Metastatic Melanoma
• Additional relevant MeSH terms: Melanoma; Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Apr 26, 2017