Lung Cancer Clinical Trial

Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

Summary

This trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with bortezomib may kill more tumor cells

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Full Description

PRIMARY OBJECTIVE:

I. To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated, progressive or recurrent, advanced non-small cell lung cancer (NSCLC).

SECOND OBJECTIVES:

I. To compare time to progression in patients with previously treated NSCLC treated with these regimens.

II. To compare 1-year and overall survival of patients treated with these regimens.

III. To compare the toxicity of these regimens in these patients. IV. To determine the pharmacokinetics of docetaxel in the context of this study.

TERTIARY OBJECTIVE:

I. To determine levels of expression of molecular markers regulated by docetaxel and bortezomib and correlate with clinical response and overall survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and number of prior chemotherapy treatments (1 vs >1). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

View Eligibility Criteria

Eligibility Criteria

Criteria:

No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years.
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Progressive or recurrent NSCLC after treatment with 1 prior platinum-based chemotherapy regimen for metastatic disease. Prior neoadjuvant/adjuvant chemotherapy and/or concurrent chemoradiation for early-stage disease allowed.
At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered.
No prior docetaxel or bortezomib
Prior epidermal growth factor receptor inhibitor therapy allowed.
Prior paclitaxel allowed
At least 4 weeks since prior major surgery and recovered.
At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsants.
No concurrent hormonal therapy, biologic therapy, or radiotherapy to measurable lesions. Concurrent palliative radiotherapy to small-field nonindicator lesions (e.g., painful bony metastases) allowed.
Measurable disease* with >= 1 unidimensionally objectively measurable lesion, including any of the following:
Lung mass (measurable on chest x-ray, tomograms, or CT scan)
Enlarged lymph nodes
Liver metastasis (measurable as a discrete focal lesion on radionuclide or CT scan, or ultrasound)
Metastatic abdominal mass (measurable on CT scan with >= 1 perpendicular diameter ≥ the distance between cuts)
Measurable disease must be outside the previous radiation field or a new lesion must be present.
Life expectancy >= 12 weeks
Progressive disease within a previously radiated field allowed.
[Note: *Measurable disease DOES NOT include bone metastases or non-focal liver metastases].
No symptomatic or untreated brain metastasis requiring steroids. Asymptomatic, previously treated (surgical resection or radiotherapy) brain metastasis allowed provided they are neurologically stable and >= 4 weeks since prior steroids.
Creatinine clearance >= 50 mL/min
Creatinine =< 1.6 mg/dL
Bilirubin normal
AST =< 2 times upper limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No peripheral neuropathy >= grade 2
Absolute granulocyte count >= 1,500/mm³
Platelet count >= 100,000/mm³
Cutaneous nodule
ECOG performance status 0-1
At least 4 weeks since prior radiotherapy and recovered.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

81

Study ID:

NCT00362882

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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City of Hope Medical Center
Duarte California, 91010, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

81

Study ID:

NCT00362882

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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