BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the overall response rate, including partial and complete response, in patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862. Determine the overall survival of patients treated with this drug. Determine duration of response and time to progression in patients treated with this drug. Determine the quantitative and qualitative toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2-4 additional courses beyond maximal response. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 14-84 patients will be accrued for this study.

Official Title
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An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: ortataxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Measurable disease A CNS lesion cannot be the sole target lesion Must be taxane-resistant as defined by the following criteria: At least 1 prior course (3 weeks of continuous therapy) of a taxane Progressive disease developed either during or within 6 months after therapy No metastatic brain or meningeal tumors unless the following criteria apply: More than 6 months since definitive therapy Negative imaging study within the past 4 weeks Clinically stable with respect to the tumor No concurrent acute steroid therapy or taper Chronic steroids allowed provided dose is stable for 1 month before and after screening radiography PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.5 times ULN (5 times ULN if liver involvement) No chronic hepatitis B or C Renal Creatinine no greater than 1.5 times ULN Cardiovascular No congestive heart failure No serious cardiac arrhythmias No active coronary disease or ischemia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative No active clinically serious infection No history of seizure disorder History of seizures related to brain metastasis allowed if seizure free for the past 2 months No prior hypersensitivity to taxane compounds that was unmanageable with premedication No pre-existing peripheral neuropathy greater than grade 1 No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, and T1) No substance abuse No medical, psychological, or social condition that would preclude study participation or evaluation No condition that is unstable or would jeopardize patient safety and study compliance PRIOR CONCURRENT THERAPY: Biologic therapy More than 3 weeks since prior anticancer immunotherapy More than 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF]) More than 4 months since prior bone marrow transplantation or stem cell rescue No concurrent anticancer immunotherapy Concurrent epoetin alfa allowed if dose is stable for the past 2 months Chemotherapy See Disease Characteristics More than 3 weeks since prior anticancer chemotherapy (6 weeks for mitomycin or nitrosoureas) No more than 2 prior anticancer chemotherapy regimens (adjuvant therapy is not included unless cancer recurred during or within 6 months after completion of adjuvant therapy) No prior oxaliplatin No other concurrent chemotherapy Endocrine therapy See Disease Characteristics Radiotherapy More than 3 weeks since prior radiotherapy No concurrent non-palliative radiotherapy Palliative radiotherapy allowed provided that all of the following criteria are met: No progressive disease No more than 10% of the bone marrow is irradiated Radiation field does not encompass a target lesion Surgery More than 4 weeks since prior surgery No prior organ allograft Other More than 4 weeks since prior investigational drug therapy No concurrent non-conventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements that would interfere with study endpoints No other concurrent investigational drug therapy No other concurrent anticancer therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ortataxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer