Abraxane and RT for Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-small Cell Lung Cancer, Stage III
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
radiation therapy
Paclitaxel Protein-Bound, and CARBOPLATIN
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer, Stage III
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
Sites / Locations
- University of Rochester, Medical Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To estimate the local tumor response rate
To estimate 2-year in-field tumor control.
To estimate 2-year disease free survival (DFS).
To estimate 2-year overall survival (OS).
Full Information
NCT ID
NCT00903942
First Posted
May 15, 2009
Last Updated
April 24, 2015
Sponsor
University of Rochester
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00903942
Brief Title
Abraxane and RT for Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Modified Two Stage Phase II Study of Combination Abraxane and Radiation for Stage III Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
funding was withdrawn from Drug company
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Rochester
Collaborators
Celgene Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Stage III
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
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
Drug
Intervention Name(s)
Paclitaxel Protein-Bound, and CARBOPLATIN
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To estimate the local tumor response rate
Time Frame
4 years
Title
To estimate 2-year in-field tumor control.
Time Frame
6 year
Title
To estimate 2-year disease free survival (DFS).
Time Frame
6 years
Title
To estimate 2-year overall survival (OS).
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuhchyau Chen, MD,PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester, Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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Abraxane and RT for Non-Small Cell Lung Cancer (NSCLC)
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