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Phase I/II Study of PS-341 in Combination With Paclitaxel, Carboplatin, and Concurrent Thoracic Radiation Therapy for Non-Small Cell Lung Cancer (NSCLC)

Phase 1/Phase 2
18 Years
Open (Enrolling)
Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

Thank you

Trial Information

Phase I/II Study of PS-341 in Combination With Paclitaxel, Carboplatin, and Concurrent Thoracic Radiation Therapy for Non-Small Cell Lung Cancer (NSCLC)


I. Determine the maximum tolerated dose of bortezomib, paclitaxel, and carboplatin when
administered with fractionated radiotherapy in patients with unresectable stage IIIA or IIIB
non-small cell lung cancer. (Phase I) (closed to accrual as of 09/29/2009) II. Determine the
1-year survival of patients treated with this regimen. (Phase II)


I. Determine the tolerability of this regimen in these patients. (Phase II) II. Determine
the response rate, progression-free survival, and overall survival of patients treated with
this regimen. (Phase II) III. Correlate p27 expression in tumor tissue with survival, time
to progression, and response in patients treated with this regimen. (Phase II)

OUTLINE: This is a multicenter, phase I (closed to accrual as of 09/29/2009),
dose-escalation study of bortezomib, paclitaxel, and carboplatin followed by a phase II

PHASE I: (closed to accrual as of 09/29/2009) Patients receive bortezomib IV on days 1, 4,
8, and 11. Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over
30 minutes on day 2. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19.
Treatment repeats every 3 weeks up to 2 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib,
paclitaxel, and carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 6 patients experience dose-limiting

PHASE II: Patients receive bortezomib, paclitaxel, and carboplatin as in phase I at the MTD.
Patients also undergo radiotherapy as in phase I. Patients are followed up periodically for
up to 5 years from the time of registration.

Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Locally advanced stage IIIA or IIIB disease that is considered unresectable

- No stage IV disease

- Requires radiotherapy

- Performance status - ECOG 0-1

- At least 12 weeks

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 3 times ULN

- Creatinine ≤ 1.5 times ULN

- No New York Heart Association class III or IV heart disease

- FEV_1 ≥ 1 L OR 35% of predicted

- Weight loss < 10% within the past 3 months

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No peripheral neuropathy ≥ grade 2

- No other severe underlying disease that would preclude study participation

- No uncontrolled infection

- No unhealed wound within the past 2 weeks

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in
situ), or localized prostate cancer

- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

- No prior systemic chemotherapy for NSCLC*

- No prior radiotherapy to the chest

- More than 2 weeks since prior major surgery

Type of Study:


Study Design:

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

Outcome Measure:

Proportion of successes, defined as the number of patients alive at one year divided by the total number of evaluable patients

Outcome Description:

Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Outcome Time Frame:

At 1 year

Safety Issue:


Principal Investigator

Alex Adjei

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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