Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.

Detailed Description
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OBJECTIVES: Primary Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy. Secondary Determine the safety of this drug in these patients. Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug. Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment. Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. OUTLINE: This is a multicenter, open-label study. Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.

Official Title
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A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: epothilone D


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or supraclavicular lymph node involvement only Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity At least 1 site of unidimensionally measurable disease by physical exam or radiography No known CNS metastases or leptomeningeal metastases requiring corticosteroids PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8 g/dL Platelet count ≥ 75,000/mm^3 Hepatic AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases) Alkaline phosphatase ≤ 5 times ULN Bilirubin ≤ 1.8 mg/dL Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No New York Heart Association class III or IV congestive heart failure No personal or family history of congenital long QT syndrome No QTc interval > 450 msec (males) or > 470 msec (females) by ECG Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No preexisting neuropathy ≥ grade 2 No other malignancy within the past 5 years except for the following: Cured basal cell skin cancer Carcinoma in situ of the cervix or urinary bladder Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy No infection requiring parenteral or oral anti-infective therapy No weight loss of ≥ 10% within the past 3 months No altered mental status or psychiatric illness that would preclude giving informed consent No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF]) No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim [G-CSF]) Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics At least 3 weeks since prior surgery and recovered Other Prior adjuvant or neoadjuvant therapy allowed Prior radiosensitizers allowed At least 2 weeks since prior gefitinib More than 3 weeks since prior investigational agents (therapeutic or diagnostic) No other concurrent investigational agents No other concurrent anticancer treatment

Ages Eligible for Study
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Minimum Age: 18 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: epothilone D|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, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer