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Phase I/II Study of Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
90 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

Phase I/II Study of Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

A chemotherapy efficacy plateau' has been reached for the treatment of patients with
advanced or metastatic non-small cell lung cancer. Platinum-based two-drug combination is
considered the current standard of care for the treatment of advanced NSCLC. There is a need
to develop novel regimens to improve the outcome for patients with advanced NSCLC. The
combination of carboplatin and docetaxel is effective for therapy of advanced NSCLC. This
combination results in improved survival and quality of life for patients with advanced
NSCLC. Docetaxel exhibits preclinical synergy with bortezomib. Hence we plan to perform a
phase I/II study to define the maximum tolerated dose of bortezomib that can be administered
in combination with docetaxel and carboplatin and subsequently evaluate the efficacy of the
regimen for patients with advanced NSCLC.

Inclusion Criteria:

- Histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion)
or stage IV NSCLC

- Age > 18 years

- ECOG PS < 2

- No prior chemotherapy

- Measurable disease

- Signed informed consent

- Adequate bone marrow function

- Adequate renal function

- Adequate hepatic function

Exclusion Criteria:

- Untreated clinically active brain metastasis

- Radiotherapy within 2 weeks prior to initiation of protocol therapy

- Treatment with any investigational therapy within 4 weeks prior to enrollment

- History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma
on situ of the cervix) within the last 5 years

- Patients in their reproductive age group should use an effective method of birth
control. Men and women of childbearing potential must be willing to consent to using
effective contraception while on treatment and for at least 3 months thereafter.
Patients who are breast-feeding will be excluded from the study. Women of
childbearing potential must have a negative pregnancy test.

- Major surgery within 3 weeks prior to enrollment

- Use of immunosuppressive agents including systemic corticosteroids within 4 weeks
prior to enrollment (corticosteroids are permitted as physiological replacement
therapy or as supportive care for nausea and emesis)

- Known history of Human immunodeficiency virus infection

- Any co-morbidity or condition of sufficient severity to limit full compliance with
the protocol per assessment by the investigator

- Concurrent serious medical infection or illness, or psychiatric illness likely to
interfere with participation in this clinical study.

- History of known hypersensitivity to docetaxel or other drugs formulated with
polysorbate 80, bortezomib, boron or mannitol

- Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.

- Myocardial infarction within 6 months prior to enrollment or has New York Hospital
Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled
angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
of acute ischemia or active conduction system abnormalities. Prior to study entry,
any ECG abnormality at Screening has to be documented by the investigator as not
medically relevant.

Type of Study:


Study Design:

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

Outcome Measure:

Determine maximum tolerated dose of bortezomib when administered in combination with carboplatin & docetaxel for treatment of patients with advanced NSCLC cancer. Determine the response rate of the combination for patients with advanced NSCLC.

Outcome Time Frame:

Expected average of 2 years

Safety Issue:


Principal Investigator

Chandra P. Belani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine


United States: Food and Drug Administration

Study ID:

PSU 26983



Start Date:

August 2008

Completion Date:

August 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • advanced non small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033