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

Celgene

Status and phase

Completed

Phase 2

Conditions

Melanoma

Metastases

Treatments

Drug: ABI-007

Study type

Interventional

Funder types

Industry

Identifiers

NCT00093119

CA014

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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