paclitaxel and abi-007 in treating patients with locally advanced or metastatic solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

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.

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.

Eligibility 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

Keywords: unspecified adult solid tumor, protocol specific