Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Purpose

The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has a broad spectrum of activity against several human cancers including carcinomas of ovary, breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against metastatic breast cancer, yielding response rates in the range of 40% to 60% in chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: ABI-007	Phase I Phase II

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	An Open-Label, Phase I/II Trial of ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle, Paclitaxel) Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by Abraxis BioScience Inc.:

Estimated Enrollment:	75
Study Start Date:	December 2003

Detailed Description:

ABI-007, a unique protein formulation of paclitaxel, has been developed to reduce the toxicities associated with Taxol and Cremophor EL/ethanol vehicle while maintaining or improving the chemotherapeutic effect of the drug.

The activity of ABI-007 in other malignancies is not yet well established. This open-label Phase I/II study is being conducted to define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of ABI-007, and evaluate the safety and antitumor activity of ABI-007 in patients with advanced Stage IV non-small cell lung cancer (NSCLC).

Eligibility

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

Criteria

Patients must be:

Histologically or cytologically confirmed advanced stage IV NSCLC with evidence of inoperable local recurrence or metastasis
If female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
Eighteen years of age or older
No other current active malignancy
Measurable disease (defined by RECIST criteria) documented radiographically
Patient must have received no prior chemotherapies for the treatment of metastatic disease. Radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. Prior treatment with EGF-targeted therapies is permitted.
If, at baseline, patient has ANC greater than or equal to 1.5 x 109 cells/L; platelets greater than or equal to 100 x 109 cells/L and Hgb greater than or equal to 9 g/dL
If, at baseline, patient has AST and ALT of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin NORMAL; creatinine levels less than or equal to 1.5 mg/dL and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
Expected survival of greater than 12 weeks
ECOG performance status 0-1 (Karnofsky > 70)
Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073723

Locations


United States, New York
	Memorial Sloan-Kettering Cancer Center
	New York, New York, United States, 10021

Sponsors and Collaborators

Abraxis BioScience Inc.

Investigators


Study Director:	Michael J Hawkins, M.D.	Abraxis BioScience Inc.

More Information

Study ID Numbers:	CA015-0
First Received:	December 3, 2003
Last Updated:	July 18, 2007
ClinicalTrials.gov Identifier:	NCT00073723
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:

Non-Small Cell Lung Cancer

Taxol

Advanced Non-Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Paclitaxel

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Abraxis BioScience Inc.
Information provided by:	Abraxis BioScience Inc.
ClinicalTrials.gov Identifier:	NCT00073723