Lung Cancer Clinical Trial

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

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Full Description

OBJECTIVES:

Primary

To determine the response rate, in terms of overall response rate (complete response and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who are ineligible for treatment with bevacizumab.

Secondary

To evaluate safety of this regimen in these patients.
To describe the overall survival of these patients.
To describe progression-free survival of these patients.

Tertiary Objectives

To explore, in a pilot fashion, the activity of this regimen using predictive biomarkers including serum SPARC levels, methylation of SPARC in primary tumor samples and serum, Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA expression profiles.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND SPARC by immunohistochemistry, and serum miRNA expression profiling.

After completion of study treatment, patients are followed periodically.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

Stage IIIB disease with malignant pleural effusion
Stage IV disease
Recurrent disease
Squamous cell histology allowed
Not eligible for curative treatment or treatment with bevacizumab
Measurable disease according to RECIST
Tumor (paraffin blocks or slides) must be available for correlative biomarker studies

No uncontrolled brain metastases (or leptomeningeal disease)

Controlled brain metastases allowed

Able to receive appropriate therapeutic radiotherapy
Able to taper off all steroids without symptoms suggestive of increased intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at least 7 days

PATIENT CHARACTERISTICS:

ECOG (Eastern Cooperative Oncology Group) performance status 0-2
ANC (absolute neutrophil count) ≥ 1.5 x 10^9/L
Platelets ≥ 100 x 10^9/L
Hemoglobin ≥ 9.0 g/L
Total bilirubin ≤ 1.5 mg/dL
AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 2.5 times upper limit of normal
Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mg/mL
No known HIV or hepatitis B or C
Not pregnant
Negative pregnancy test
Thrombotic or embolic event within the past 6 months allowed, provided adequately controlled with therapeutic anticoagulation
Hemoptysis allowed, provided it is not life threatening or requires palliative procedures (e.g., endobronchial therapy or radiotherapy)

No cardiac disease, including any of the following:

NYHA (New York Heart Association) class III-IV congestive heart failure
Unstable angina (angina symptoms at rest)
New onset angina (began within the past 3 months)
Myocardial infarction within the past 6 months
No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management
No peripheral neuropathy ≥ grade 2
No active clinically serious infection > CTCAE grade 2
No serious non-healing wound, ulcer, or bone fracture
No significant traumatic injury within the past 4 weeks
No evidence or history of bleeding diathesis or coagulopathy

No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 2 years

Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of NSCLC allowed, however metastatic prostate cancer currently receiving hormonal therapy or chemotherapy is not allowed
No significant psychiatric illness, in the opinion of the principal investigator, that would prevent adequate informed consent or render therapy unsafe

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Concurrent therapeutic anticoagulation, > 325 mg acetylsalicylic acid, or chronic non-steroid anti-inflammatory drug use allowed
At least 14 days since prior and no concurrent radiotherapy
More than 4 weeks since prior major surgery or open biopsy

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT00729612

Recruitment Status:

Completed

Sponsor:

Greg Otterson

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There is 1 Location for this study

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Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT00729612

Recruitment Status:

Completed

Sponsor:


Greg Otterson

How clear is this clinincal trial information?

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