Status:
TERMINATED
Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II trial of abraxane and carboplatin in extensive stage small cell lung cancer to examine overall response rate, time to progressive disease, survival time, and assessment of toxicity ...
Detailed Description
Patients are being asked to be in this study because they have extensive disease small cell lung cancer. All eligible participants who agree to be in the study will receive both abraxane and carboplat...
Eligibility Criteria
Inclusion
- Histological or cytological diagnosis of extensive stage small-cell lung cancer (ES-SCLC),\* including malignant pleural effusion
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC
- Measurable disease as defined by the RECIST criteria
- Adequate organ function as defined by the protocol
- Female patients of child bearing potential (CBP) must agree to use of reliable method of birth control during and for 3 months following treatment
- Patients must sign informed consent document
- Patients must be ≥ 18 years of age
- Patients with brain metastases that have been adequately treated and are determined to be controlled by the attending physician are eligible
- Patients who have had prior malignancies are eligible if they are ≥ 5 years from diagnosis free of disease or the attending physician believes the patient's prognosis is best defined by the ES-SCLC (if questions concerning this eligibility criteria arise, please contact the principal investigator)
- (\*)ES-SCLC defined as metastases outside the chest, pulmonary metastases, or contralateral metastases (supraclavicular or hilar) nodes that could not be included with a reasonable single radiation port. Patients with malignant pleural effusions are considered extensive stage.
Exclusion
- Received treatment within the last 30 days with a drug that has not received Food and Drug Administration (FDA) approval for any indication at the time of study entry
- Pregnancy or breast feeding
- Serious active infection that would require a prolonged course (4-6 weeks) of antibiotics or would compromise the safety of the patient or compromise the patient's ability to complete the study
- Symptomatic brain metastases
- Grade ≥ 2 neuropathy using NCI CTCAE version 3.0 criteria
- Previous anaphylactic reaction to carboplatin, paclitaxel, and docetaxel
- Severe or uncontrolled cardiac disease, defined as uncontrolled or unstable angina, myocardial infarction in the last month, uncontrolled congestive heart failure (≥ 3 admissions for congestive heart failure in the 3 months prior to diagnosis)
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00454324
Start Date
April 1 2006
End Date
December 1 2014
Last Update
July 11 2017
Active Locations (1)
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1
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599-7295