Protocol Number: 04-C-0280

Title:

Randomized, Crossover, Pharmacokinetic Study of Paclitaxel (Taxol) and ABI-007 (a Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) in Patients with Advanced Solid Tumors

Number:

04-C-0280

Summary:

This study will examine and compare the way patients with advanced solid tumor cancers handle two drugs: Taxol and ABI-007. Both drugs contain the active ingredient paclitaxel, but they differ in the inactive components that are needed to allow paclitaxel to be given intravenously (by vein). Taxol is an effective treatment for several types of cancers, including breast, ovary and lung. The effectiveness of the experimental drug ABI-0007 is very similar to that of Taxol, but ABI-0007 has other characteristics that may make it preferable to Taxol, such as a shorter infusion time without the need to take some additional medicines to prevent unwanted side effects.

Patients 18 years of age and older with solid tumor cancers that are incurable, locally advanced, or that have metastasized (spread beyond the original site) and that are likely to respond to paclitaxel may be eligible for this study. Candidates are screened with laboratory (blood and urine) tests, an electrocardiogram, and imaging studies, including chest x-ray, computed tomography (CT) scans of the chest and abdomen, a bone scan in patients with bone metastases, and a MUGA scan or echocardiogram.

Participants receive both Taxol and ABI-0007 by vein in 21-day treatment cycles. Taxol is infused over 3 hours, and ABI-0007 is infused over 30 minutes. Patients begin treatment with either Taxol or ABI-0007 for the first cycle, and then receive the other drug for the second cycle. ABI-0007 is given for all subsequent cycles. The total number of cycles a patient receives depends on his or her individual clinical situation. Before receiving Taxol, patients take two doses of dexamethasone, a dose of diphenhydramine, and a dose of ranitidine to help prevent reactions to the Taxol infusion. Before the ABI-0007 infusions, patients are given diphenhydramine and ranitidine, but not dexamethasone.

In addition to drug treatment, patients have a tumor biopsy (surgical removal of a small piece of tumor) or a needle aspiration of the tumor (withdrawal of tumor cells through a needle), if possible. Blood samples are collected before and at several time points starting 15 minutes to 72 hours after the study drugs are infused. The blood is analyzed for paclitaxel levels following administration of Taxol and ABI-0007 and for analysis of blood proteins. Patients must stay in the area of the NIH Clinical Center for 3 days in the first three treatment cycles in order to collect the blood needed for sampling, and for the day of drug administration for subsequent cycles.

Patients whose tumors grow during treatment are taken off the study and offered participation in other appropriate studies, if available, or returned to the care of their referring physician.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Carcinoma

Pharmacology

Disposition

Formulation

Plasma

Recruitment Keyword(s):

Solid Tumor

Malignant Solid Tumor

Carcinoma

Condition(s):

Melanoma

Metastases

Investigational Drug(s):

ABI-007

Investigational Device(s):

None

Interventions:

Drug: ABI-007

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Wani MC, Taylor HL, Wall ME, Coggon P, McPhail AT. Plant antitumor agents. VI. The isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia. J Am Chem Soc. 1971 May 5;93(9):2325-7.

Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer. 2001 Sep;37(13):1590-8.

Adams JD, Flora KP, Goldspiel BR, Wilson JW, Arbuck SG, Finley R. Taxol: a history of pharmaceutical development and current pharmaceutical concerns. J Natl Cancer Inst Monogr. 1993;(15):141-7.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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