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Cancer Treatment Followed by Surgery for Early Stage Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00313690
Recruitment Status : Withdrawn (Recruitment difficulties)
First Posted : April 12, 2006
Last Update Posted : May 21, 2014
Information provided by:
University of Southern California

Brief Summary:
  • The purpose of the phase I portion of the study is to determine the safety and feasibility of neoadjuvant bortezomib in combination with docetaxel and cisplatin followed by surgery in early stage non-small cell lung cancer, via a multi-cohort dose escalation trial.
  • The phase II portion of the study will look at the clinical response rate and the pathology response rate. Other purposes are to look at surgical morbidity, mortality and respectability rates. Molecular correlates of response and survival to this neoadjuvant regimen will be explored.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Bortezomib, Docetaxel and Cisplatin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Neoadjuvant Bortezomib in Combination With Docetaxel and Cisplatin Followed by Surgery in Early Stage Non-Small Cell Lung Cancer.
Study Start Date : April 2006

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:(Phase I and II unless otherwise specified)

  • Potential subjects may either be suspected to have non-small cell lung cancer with plans for a diagnostic biopsy, or must have a histological or cytological diagnosis of non-small cell lung cancer. For those suspected of having non-small cell lung cancer, histological confirmation must be obtained prior to commencing treatment on protocol. During the phase II portion of this protocol, all subjects will be asked to undergo FNA/core biopsy of the primary tumor for correlative studies even if they already came to screening with prior biopsy (histological confirmation of disease). However, subjects refusing repeat FNA/core biopsy will not be excluded from protocol entry
  • Subjects must have stage IB ,IIA ,or IIIA. T stage must be defined by CT and PET imaging. Nodal status must be determined by CT/PET imaging, N2 disease must be confirmed by mandatory mediastinoscopy
  • Subjects must be chemotherapy and radiation therapy naïve
  • No history of prior malignancy except adequately treated basal cell or squamous cell skin cancer, or adequately treated cervical carcinoma in situ.
  • Age greater than 18 years.
  • Zubrod performance status of 0 or 1.
  • Patients must have adequate organ and marrow function as defined below:
  • absolute neutrophil count greater than or equal to 1,500
  • platelets greater than or equal to 100,000/ml
  • total bilirubin within normal institutional limits
  • hemoglobin greater than 8.0 g/dl
  • AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
  • Creatinine within normal institutional limits OR Calculated creatinine clearance greater than or equal to 60 ml/min.
  • Female subject of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry, during treatment and for at least 3 months thereafter. Women of child bearing potential must have a documented negative pregnancy associated ß-HCG during screening.
  • Predicted post-resection FEV1 of 1.0 L or more
  • Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

  • Subjects must not be receiving nor plan on receiving any other investigational agents.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  • History of known allergy to compounds of similar chemical or biologic composition to bortezomib or other agents used in this study (i.e. Boron, Mannitol).
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, congestive heart failure or myocardial infarction within the preceding 6 months, symptomatic cardiac arrhythmia, unstable angina pectoris, psychiatric illness or social situations that would limit compliance with study prescribed therapy.
  • Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients are excluded from the study.
  • Pregnant or nursing women
  • Peripheral neuropathy: greater than grade 1
  • Inclusion of Women and Minorities

Both men and women of all ethnic groups are eligible for this trial if they meet the eligibility criteria. To date, there is no information that suggests differences in drug metabolism or disease response would be expected in one group compared to another. All efforts will be made to accrue a representative sample. If differences in outcome appear to be associated with gender or ethnicity, then perhaps a follow-up study can be designed to investigate these differences more fully. The catchment's area for USC is Los Angeles County.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00313690

Sponsors and Collaborators
University of Southern California
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Principal Investigator: Barbara Gitlitz, MD USC Comprehensive Cancer Center
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Responsible Party: Barbara Gitlitz, MD, University of Southern California Identifier: NCT00313690    
Other Study ID Numbers: 2N-05-2
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by University of Southern California:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action