Status and phase
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About
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.
Full description
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.
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignant solid tumor
Likely to be responsive to taxane-based therapy
No symptomatic or untreated brain metastasis or carcinomatous meningitis
No previously untreated locally advanced breast cancer
No hematologic malignancy
PATIENT CHARACTERISTICS:
Age
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Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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