Status:
COMPLETED
Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung Cancer
Lead Sponsor:
PrECOG, LLC.
Collaborating Sponsors:
AstraZeneca
Conditions:
Lung Cancer
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
It has been shown in previous studies that the ability to treat lung cancer could be significantly improved by not only targeting the tumor cells directly with chemotherapy, but also by cutting off th...
Detailed Description
Lung cancer is the number one cause of cancer-related mortality in the United States, with an estimated 160,390 deaths in 2007. Over 80% of these patients will have non-small cell lung cancer (NSCLC),...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed non-small cell lung cancer
- Advanced disease (stage IIIB disease \[malignant pleural or pericardial effusion seen on CT or Chest X-ray, any N, M0\] or stage IV disease \[Any T, any N, M1: distant metastases\]) that is primary or recurrent
- Measurable disease according to the RECIST criteria
- ECOG Performance Status 0 or 1
- Adequate organ function, as evidenced by ALL the following
- Absolute neutrophil count (ANC) ≥ 1500/mm³ and platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 gm/dL
- Total bilirubin ≤ 1 X institutional ULN; if patient has Gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin ≤ 2 X institutional ULN.
- AST, ALT and alkaline phosphatase (Alk Phos) must be ≤ 1.5 ULN
- Creatinine ≤ 1.5 X institutional ULN or calculated creatinine clearance ≥ 60 ml/min
- Potassium between 4 mEq/L and institutional ULN (supplementation may be used),
- Calcium (ionized or adjusted for albumin)within institutional normal limits
- Magnesium within institutional normal limits (supplementation may be used)
- No prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease (Prior adjuvant therapy for lung cancer allowed if completed \> 1 year prior to registration)
- Able to take oral medication
Exclusion
- Myocardial infarction, superior vena caval syndrome, NYHA classification of heart disease ≥ 2 within the 3 months prior to entry
- History of an uncontrolled or recurrent ventricular, supraventricular or nodal arrhythmia that requires treatment
- Hypertension not controlled by medication
- Peripheral or sensory neuropathy \> grade 1
- Known hypersensitivity to carboplatin or docetaxel
- Active infection
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00687297
Start Date
April 1 2008
End Date
April 1 2011
Last Update
May 30 2018
Active Locations (30)
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1
Boca Raton Community Hospital
Boca Raton, Florida, United States, 33486
2
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
3
SwedishAmerican Hospital
Rockford, Illinois, United States, 61104
4
Cancer Center of Kansas
Wichita, Kansas, United States, 67214