Abraxane and RT for Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00903942
Recruitment Status : Withdrawn (funding was withdrawn from Drug company)
First Posted : May 19, 2009
Last Update Posted : April 27, 2015
Celgene Corporation
Information provided by:
University of Rochester

May 15, 2009
May 19, 2009
April 27, 2015
March 2008
March 2012   (Final data collection date for primary outcome measure)
To assess feasibility of one cycle induction chemotherapy of Abraxane plus Carboplatin followed by low-dose sensitizing Abraxane and radiation followed by consolidation Abraxane and carboplatin for stage III NSCLC. [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT00903942 on Archive Site
  • To estimate the local tumor response rate [ Time Frame: 4 years ]
  • To estimate 2-year in-field tumor control. [ Time Frame: 6 year ]
  • To estimate 2-year disease free survival (DFS). [ Time Frame: 6 years ]
  • To estimate 2-year overall survival (OS). [ Time Frame: 6 years ]
Same as current
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Abraxane and RT for Non-Small Cell Lung Cancer (NSCLC)
A Modified Two Stage Phase II Study of Combination Abraxane and Radiation for Stage III Non-Small Cell Lung Cancer
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 be followed by more hi-dose chemotherapy. We anticipate this regimen to target early distant microscopic spread by using one cycle of chemotherapy prior to radiation, and to achieve control of the disease in the lung by combining pulsed low-dose sensitizing Abraxane, with radiation.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer, Stage III
  • Radiation: radiation therapy
    1) PTV = CTV (GTV + 1.5-cm margins and the most adjacent nodal regions) + 0.5 cm margins to 5,040 cGy in 180 cGy daily fractions; and (2) Cone Down PTV = GTV +1.5 cm margins to 6,480 cGy.
  • Drug: Paclitaxel Protein-Bound, and CARBOPLATIN
    Induction Chemotherapy Abraxane(260 mg/m2) / Carboplatin (AUC of 6) x one cycle Concurrent Chemotherapy(with radiation)--for first 3 pts--20 mg/m2 Abraxane, 3 times per week then for next group of 3 pts--30 mg/m2 Abraxane twice a week
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Yuhchyau Chen, MD, Ph.D, University of Rochester, Medical Center
University of Rochester
Celgene Corporation
Principal Investigator: Yuhchyau Chen, MD,PhD University of Rochester
University of Rochester
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP