A Trial of ABI-007 in Patients With Advanced Non-Hematologic Malignancies

Celgene

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Metastases, Neoplasm

Treatments

Drug: ABI-007

Study type

Interventional

Funder types

Industry

Identifiers

NCT00046423

CA-005-0

Details and patient eligibility

About

This trial will treat patients with advanced (metastatic) cancer with a new chemotherapeutic agent that may be more readily tolerated than some standard therapies. Patients will be given the new chemotherapeutic medicine once a week, by intravenous route, for three weeks, followed by a rest week. Treatment will be repeated in four week cycles if the patient improves on the therapy, and if there are no adverse events that require withdrawal of medication.

Full description

This will be a dose-escalating study. ABI-007 will be administered as an outpatient infusion for three weeks followed by a week of rest. The treatment course will repeat every 28 days. No pretreatment will normally be considered necessary. Patients will have white blood cell and platelet counts monitored as will indications of performance (Karnofsky Performance Status), and will be asked to describe adverse events, if present. Patients will be treated for a minimum of two cycles to be evaluable for the study, and may continue in the study for four cycles within the study, if tumor response and safety parameters warrant continuing. Patients may continue on study medication beyond this at the investigator's discretion.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

At least 18 years of age
Life expectancy of at least 2 months
Off all therapy for at least 3 weeks prior to study drug administration
Biopsy-proven diagnosis of advanced malignancy
Patients with solid tumors who have failed standard therapy
Karnofsky Performance Status of 70% or 0-2 SWOG Performance Status
Hemoglobin at least 9
White Blood Cell count of at least 3000/mm3 with absolute neutrophil count of at least 1500/mm3
Platelet count of at least 100,000/mm3
Serum Creatinine less than 2 mg/dL
Transaminases less than 3X the upper limit of normal
Patient must provide informed consent
Serum Bilirubin less than 1.5 mg/dL