Clinical trial NCT00040768: Bortezomib in Treating Patients With Advanced Non-small Cell Lung Cancer
Official title: A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II trial to study the effectiveness of bortezomib in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer. Bortezomib may interfere with the growth of tumor cells by blocking certain enzymes necessary for tumor cell growth

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate to PS-341 therapy
timeFrame: Up to 4 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to 4 months
measure: Overall survival
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: James Stevenson
role: PRINCIPAL_INVESTIGATOR
References: