Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.

Study summary:

OBJECTIVES: Primary - Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel. Secondary - Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients. - Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients. - Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen. OUTLINE: This is a randomized, pilot study. - Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and ABI-007 IV over 30 minutes on day 22. - Arm II: Patients receive ABI-007 IV over 30 minutes on day 1 and paclitaxel IV over 3 hours on day 22. - Courses 3 and beyond: All patients receive ABI-007 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.


DISEASE CHARACTERISTICS: - Histologically confirmed malignant solid tumor - Considered incurable - Locally advanced or metastatic disease - Likely to be responsive to taxane-based therapy - Patients who are refractory to prior paclitaxel are ineligible - No symptomatic or untreated brain metastasis or carcinomatous meningitis - No patients who are unable to remain free of corticosteroid therapy for > 4 weeks due to CNS disease - No previously untreated locally advanced breast cancer - No hematologic malignancy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin normal - ALT and AST ≤ 1.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance ≥ 60 mL/min Cardiovascular - LVEF ≥ 40% - No clinical signs or symptoms of heart failure - No symptomatic congestive heart failure - No unstable angina pectoris Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study participation - No history of allergic reaction attributed to compounds of similar chemical or biologic composition to paclitaxel (e.g., docetaxel, Cremophor^® EL [CrEL], polysorbate 80 [Tween 80], or CrEL-containing medications [e.g., cyclosporine]) - No history of seizure disorder requiring anticonvulsant therapy - No active serious infection - No psychiatric illness or social situation that would preclude study compliance - No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy - No concurrent filgrastim (G-CSF) during courses 1 and 2 Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - At least 2 weeks since prior hormonal therapy - Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed Radiotherapy - At least 3 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 2 weeks since prior drugs, herbal preparations, or dietary supplements known to influence CYP3A4 (e.g., phenytoin, rifampin, Hypericum perforatum [St. John's wort], garlic supplements, or grapefruit juice) and/or CYP2C8 - No concurrent substances known or likely to interfere with the pharmacokinetics of paclitaxel (e.g., verapamil or cyclosporine) - No other concurrent investigational agents - No other concurrent anticancer therapy



Primary Contact:

Study Chair
William D. Figg, PharmD
National Cancer Institute (NCI)

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.