Status:
COMPLETED
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
Greg Otterson
Collaborating Sponsors:
National Comprehensive Cancer Network
Celgene Corporation
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 c...
Detailed 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 carbop...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00729612
Start Date
August 14 2008
End Date
December 16 2011
Last Update
April 2 2018
Active Locations (1)
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1
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210