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

Sponsored by:	Abraxis BioScience Inc.
Information provided by:	Abraxis BioScience Inc.
ClinicalTrials.gov Identifier:	NCT00046423

Purpose

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.

Condition	Intervention	Phase
Neoplasms Metastases, Neoplasm	Drug: ABI-007	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Trial of ABI-007 Administered Weekly for Three Doses Every 4 Weeks in Patients With Advanced Non-Hematologic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Abraxis BioScience Inc.:

Estimated Enrollment:	20
Study Start Date:	April 2000

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 Perfomance 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046423

Locations

United States, North Carolina
Abraxis Bioscience, Inc.
Durham, North Carolina, United States, 27703

Sponsors and Collaborators

Abraxis BioScience Inc.

Investigators

Study Director:

Michael J Hawkins, M.D.

Abraxis BioScience Inc.

More Information

No publications provided

Study ID Numbers:	CA-005-0
Study First Received:	September 30, 2002
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00046423 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:

Cancer
solid tumor
Advanced malignancy

Taxane therapy
Biopsy-proven diagnosis of advanced malignancy
Various solid tumors which are refractory

Study placed in the following topic categories:

Paclitaxel
Neoplasm Metastasis
Taxane

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on July 02, 2009