Status:
WITHDRAWN
Abraxane and RT for Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Celgene Corporation
Conditions:
Non-small Cell Lung Cancer, Stage III
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
For patients with stage III Lung Cancer, We propose one cycle chemotherapy using Abraxane and Carboplatin, followed by pulsed low-dose sensitizing Abraxane chemotherapy and daily Radiation. This will ...
Eligibility Criteria
Inclusion
- Histologically confirmed NSCLC.
- Clinical or pathologic stage IIIA (T1-3N2M0, T3N1M0) and IIIB (Any T N3M0, T4 Any N M0) diseases according to the American Joint Committee of Cancer criteria.
- Patients with malignant pleural effusion will be excluded.
- The primary tumor must be radiographically measurable.
- Age \> 18.
- Karnofsky performance status \> 70 or Zubrod PS 0 or 1.
- FEV1 sufficient for patients to tolerate radiation therapy, which is at the discretion of the radiation oncologist, usually \> 800 ml, but may be higher or lower depending on the volume of radiotherapy portal, which is a variable of the tumor extent.
- WBC \> 3000; platelet count \> 100,000; absolute neutrophil counts \> 1,500; HGB \> 9.0 g/dl, serum creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/min. Laboratory values must be obtained \< 4 weeks prior to registration.
- Patients with equivocal enlargement of adrenal gland(s) on CT scan, or a few equivocal regional or distant lesions on any imaging studies need further imaging study (PET, bone scan, or others) or biopsy to rule out distant metastasis.
- Patients must have adequate liver functions: AST and ALT \< 2.5 x upper limit of normal, alkaline phosphatase \< 2.5 x upper limit of normal, unless bone metastasis is present in the absence of liver metastasis. Bilirubin \<1.5 mg/dL.
- Pre-existing neuropathy must not be worse than grade I.
- A signed informed consent.
- Normal organ function including EKG findings deemed acceptable for chemotherapy by the medical oncologist.
Exclusion
- Patients with distant metastasis (stage IV disease).
- Patients without measurable disease.
- Patients with medical contraindication to chemotherapy or radiotherapy.
- Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmia.
- Patients with bilirubin elevated above institutional upper limit of normal (ULN) must be excluded.
- Women who are pregnant or breastfeeding are not eligible.
- Other serious illnesses or medical conditions
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00903942
Start Date
March 1 2008
Last Update
April 27 2015
Active Locations (1)
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1
University of Rochester, Medical Center
Rochester, New York, United States, 14642