Status:
TERMINATED
A Study of CBT-1 and Paclitaxel With Carboplatin in Patients With Advanced Inoperable Non-small Cell Lung Cancer
Lead Sponsor:
CBA Research
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action. Drug resistance remains a significant impediment to successful cance...
Detailed Description
Lung cancer has the highest incidence and prevalence among cancers in the world and remains the leading cause of cancer-related deaths in Western countries. One-year survival of patients with best sup...
Eligibility Criteria
Inclusion
- histological confirmed diagnosis of NSCLC
- advanced inoperable NSCLC
- have adequate renal function, serum creatinine \<2.0 mg/dL or 24 hour creatinine clearance \> 50mL/minute
- have adequate liver function defined as SGOT \<4 times the upper limit of normal (ULN) and bilirubin \<2.0 mg/dL
- have calcium \<11.0 mg/dL and albumin \>2.0g/dL
- have adequate bone marrow reserve defined as granulocyte count \>1,500/mm3, hemoglobin \>10.0 g/dL and platelets \>100,000/mm3
- if female and of child-bearing potential, agree to use one of the following methods of birth control: oral contraceptives, barrier with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse
Exclusion
- have previously received taxanes, platinums, vinca alkaloids, anthracyclines, epipodophyllotoxins or CBT-1
- have known or suspected hypersensitivity to platinum containing compounds, taxanes, polyoxyethylated castor oil, or mannitol
- have significant central nervous system disease, including history of seizures within last 3 months or psychiatric history which would impair the ability to give informed consent or prevent compliance with protocol requirements
- be eligible for curative surgery or radiotherapy.
- must not have a diagnosis and/or treatment in the past 5 years of any malignancy other than NSCLC or basal cell carcinoma of the skin
- be pregnant or nursing
- have a history of significant coronary artery disease, cardiac arrhythmias requiring treatment, history of other cardiac disease or other cardiac anomalies determined by ECG which in the judgment of the investigator would compromise the patient's ability to tolerate the therapy
- have ongoing serious infections that require parenteral antibiotics
- have clinically significant bleeding disorders
- have solid organ allograft
- have significant intercurrent disease
- have bleeding peptic ulcer disease
- have participated in any experimental study within 2 months preceding enrollment
- be using a medication that could interact adversely with CBT-1, paclitaxel, or carboplatin. Medications include:aminoglycoside antibiotics, Prilosec, Losec, Zantac
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00437749
Start Date
August 1 2001
End Date
November 1 2010
Last Update
September 9 2011
Active Locations (1)
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1
Arizona Clinical Research Center
Tuscon, Arizona, United States, 85715