Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00077246


Primary Contact:

Study Chair
Naiyer Rizvi, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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