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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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