Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
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.
Detailed 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
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
Countries
United States