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

NCT ID: NCT00903942

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31

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 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.

Conditions

Non-small Cell Lung Cancer, Stage III

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: RADIATION

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

University of Rochester, Medical Center

Principal Investigators

Yuhchyau Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester, Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

RSRB00022397

Identifier Type: -

Identifier Source: org_study_id