Lung Cancer
Conditions
Keywords
stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007 | — |
| Objective target lesion response (complete or partial) as measured by RECIST criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in hematologic and clinical chemistry values | — |
| Changes in physical examination | — |
| Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment | — |
| Percentage of patients with stable disease for ≥ 16 weeks | — |
| Incidence of treatment-emergent adverse events and serious adverse events | — |
| Time to disease progression | — |
| Duration of response | — |
| Survival | — |
| Percentage of patients with complete or partial target response (total response) | — |
| Nadir of myelosuppression | — |
Countries
United States