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

This study has been withdrawn prior to enrollment.
(funding was withdrawn from Drug company)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00903942
First received: May 15, 2009
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer, Stage III
Radiation: radiation therapy
Drug: Paclitaxel Protein-Bound, and CARBOPLATIN
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Modified Two Stage Phase II Study of Combination Abraxane and Radiation for Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate the local tumor response rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To estimate 2-year in-field tumor control. [ Time Frame: 6 year ] [ Designated as safety issue: No ]
  • To estimate 2-year disease free survival (DFS). [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • To estimate 2-year overall survival (OS). [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00903942

Locations
United States, New York
University of Rochester, Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Celgene Corporation
Investigators
Principal Investigator: Yuhchyau Chen, MD,PhD University of Rochester
  More Information

No publications provided

Responsible Party: Yuhchyau Chen, MD, Ph.D, University of Rochester, Medical Center
ClinicalTrials.gov Identifier: NCT00903942     History of Changes
Other Study ID Numbers: RSRB00022397
Study First Received: May 15, 2009
Last Updated: May 18, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014