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A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer


PRIMARY OBJECTIVES:

I. Determine the response rate, time to progression, and survival of patients with advanced
non-small cell lung cancer treated with bortezomib.

II. Determine the toxicity of this drug in these patients. III. Correlate toxicity and
activity of this drug with markers of proteasome inhibition in blood and peripheral
mononuclear cells in these patients.

OUTLINE:

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity. Patients who
received prior bortezomib and achieved at least a partial response of at least 6 months
duration may also receive therapy as above.


Inclusion Criteria:



- Histologically or cytologically confirmed non-small cell lung cancer

- Mixed tumors allowed unless small cell elements are present

- Stage IIIB or IV or recurrent disease

- At least 1 measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral
CT scan

- No known brain metastases

- Performance status - ECOG 0-1

- More than 3 months

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

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 2 mg/dL

- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver
involvement present)

- Creatinine ≤ 2 mg/dL

- Creatinine clearance ≥ 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No peripheral neuropathy > grade 1

- No other concurrent uncontrolled illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study participation

- No more than 1 prior chemotherapy regimen

- Two prior chemotherapy regimens allowed provided 1 of the 2 regimens was
gefitinib monotherapy as second-line therapy

- At least 4 weeks since prior chemotherapy (6 weeks for carmustine, mitomycin, or
nitrosoureas) and recovered

- At least 4 weeks since prior radiotherapy (except localized radiotherapy for symptom
relief) and recovered

- Prior bortezomib allowed provided patient achieved at least a partial response (of at
least 6 months duration), received no other therapy since the last dose of
bortezomib, and has no residual toxicity greater than grade 1

- No other concurrent investigational or commercial agents or therapies for malignancy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate to PS-341 therapy

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

James Stevenson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02470

NCT ID:

NCT00040768

Start Date:

April 2002

Completion Date:

Related Keywords:

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

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283