View Clinical Trial (Medical Research Study)
Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding From VEGF Directed Therapies
| City: |
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Columbus |
| State: |
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Ohio |
| Zip Code: |
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43210 |
| Conditions: |
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Lung Cancer |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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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 performance status 0-2
- ANC ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 9.0 g/L
- Total bilirubin ≤ 1.5 mg/dL
- AST and ALT < 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 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
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| NCT ID: |
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NCT00729612 |
| Primary Contact: |
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Principal Investigator
Gregory A. Otterson, MD
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbus, Ohio 43210
United States
Gregory A. Otterson, MD
Phone: 866-627-7616
Email: osu@emergingmed.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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