NCT00903942

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

May 15, 2009

Last Update Submit

April 24, 2015

Conditions

Non-small Cell Lung Cancer, Stage III

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 years

Secondary Outcomes (4)

  • To estimate the local tumor response rate

    4 years

  • To estimate 2-year in-field tumor control.

    6 year

  • To estimate 2-year disease free survival (DFS).

    6 years

  • To estimate 2-year overall survival (OS).

    6 years

Interventions

radiation therapyRADIATION

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.

Paclitaxel Protein-Bound, and CARBOPLATINDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester, Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

RadiotherapyTaxesCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsEconomicsHealth Care Economics and OrganizationsCoordination ComplexesOrganic Chemicals

Study Officials

  • Yuhchyau Chen, MD,PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 19, 2009

Study Start

March 1, 2008

Primary Completion

March 1, 2012

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations

US(1)