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

Neoplasms Clinical Trial

Official title:

A Phase I Trial of ABI-007 Administered Weekly for Three Doses Every 4 Weeks in Patients With Advanced Non-hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046423
• Other study ID #: CA-005-0
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2002
• Last updated: November 23, 2016
• Start date: April 2000

Study information

• Verified date: November 2016
• Source: Celgene Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastases, Neoplasm
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• ABI-007

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nyman DW, Campbell KJ, Hersh E, Long K, Richardson K, Trieu V, Desai N, Hawkins MJ, Von Hoff DD. Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies. J Clin Oncol. 2005 Nov 1;23(31):7785-93. — View Citation