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A Modified Two Stage Phase II Study of Combination Abraxane and Radiation for Stage III Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer, Stage III

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Trial Information

A Modified Two Stage Phase II Study of Combination Abraxane and Radiation for Stage III Non-Small Cell Lung Cancer

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Yuhchyau Chen, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer, Stage III
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Rochester, Medical Center Rochester, New York  14642