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Phase I/II Study of Neoadjuvant Bortezomib in Combination With Docetaxel and Cisplatin Followed by Surgery in Early Stage Non-Small Cell Lung Cancer.

Phase 1/Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase I/II Study of Neoadjuvant Bortezomib in Combination With Docetaxel and Cisplatin Followed by Surgery in Early Stage Non-Small Cell Lung Cancer.

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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Barbara Gitlitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800