abi-007 in treating patients with chemotherapy-naïve stage iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as abi-007, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase i/ii trial is studying the side effects and best dose of abi-007 and to see how well it works in treating patients with stage iv non-small cell lung cancer.

objectives: primary * determine the maximum tolerated dose and dose-limiting toxicity of paclitaxel (albumin-stabilized nanoparticle formulation) (abi-007) in patients with chemotherapy-naïve stage iv non-small cell lung cancer. * determine the antitumor activity of this drug in these patients. * determine the safety and tolerability of this drug in these patients. secondary * determine the time to disease progression in patients treated with this drug. * determine duration of response in patients treated with this drug. * determine survival of patients treated with this drug. outline: this is an open-label, dose-escalation study. * phase i: patients receive paclitaxel (albumin-stabilized nanoparticle formulation) (abi-007) iv on days 1, 8, and 15. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of abi-007 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * phase ii: patients receive abi-007 as above at the mtd (determined in phase i). patients are followed monthly for 6 months and then every 3 months for 1.5 years. projected accrual: a total of 64 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed stage iv non-small cell lung cancer * evidence of inoperable local recurrence or metastasis * bone metastases or other nonmeasurable disease may not be only evidence of metastasis * measurable disease documented radiographically * no evidence of active brain metastases or leptomeningeal involvement patient characteristics: age * 18 and over performance status * ecog 0-1 or * karnofsky 80-100% life expectancy * more than 12 weeks hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 9 g/dl hepatic * ast and alt ≤ 2.5 times upper limit of normal (uln) * bilirubin normal * alkaline phosphatase ≤ 2.5 times uln (unless due to bone metastases and there is no radiologic evidence of hepatic metastases) renal * creatinine ≤ 1.5 mg/dl other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception for 1 month before and during study participation * no prior allergy or hypersensitivity to study drug * no other concurrent active malignancy * no pre-existing peripheral neuropathy grade 1 or greater * no other concurrent clinically significant illness * no concurrent serious medical risk factor involving any of the major organ systems that would preclude study participation prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy for metastatic disease * more than 4 weeks since prior cytotoxic chemotherapy * no concurrent doxorubicin * no other concurrent taxanes * no concurrent anthracyclines endocrine therapy * not specified radiotherapy * at least 3 weeks since prior radiotherapy to a major bone marrow-containing area * more than 4 weeks since prior radiotherapy except to a non-target lesion * prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since completion of radiotherapy surgery * not specified other * prior epidermal growth factor-targeted therapy allowed * more than 4 weeks since prior investigational drugs * no concurrent enrollment in another clinical trial in which investigational drugs are administered or investigational procedures are performed * no concurrent treatment with any of the following: * ritonavir * saquinavir * indinavir * nelfinavir * no concurrent anticonvulsants * no other concurrent anticancer drugs * no other concurrent investigational drugs

Keywords: stage iv non-small cell lung cancer recurrent non-small cell lung cancer