Lung Cancer Clinical Trial

Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with selenomethionine and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

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Full Description

OBJECTIVES:

Primary

Determine the safety and tolerability of selenomethionine in combination with chemotherapy and radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
Determine if the incidence of excessive adverse events, in the form of esophagitis, pneumonitis, and myelosuppression, can be reduced with this regimen.

Secondary

Estimate response rate, failure-free survival, and overall survival of these patients.
Correlate selenium levels with degree of observed adverse events.

OUTLINE: This is a multicenter study.

Patients receive oral selenomethionine twice daily for 1 week and then once daily for 6 weeks. Patients also receive paclitaxel IV over 1 hour once weekly and carboplatin IV over 30 minutes once weekly for 6 weeks and undergo radiotherapy 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and weekly during treatment and analyzed by absorption spectrophotometry for selenium measurement of drug concentration

After the completion of study treatment, patients are followed periodically.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:

Squamous cell carcinoma
Adenocarcinoma (including bronchoalveolar cell carcinoma)
Large cell anaplastic carcinoma (including giant and clear cell carcinoma)

Stage IIIA disease OR selected stage IIIB disease

T1-2, N2 disease OR T3, N2 or T4, N0-N2 disease (if based on tumor closeness to the carina, invasion of the mediastinum, or invasion of the chest wall)

Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiation boost field

Tumors adjacent to a vertebral body allowed unless there is demonstrable bone invasion

All gross disease must be able to be encompassed in the radiation boost field
No direct invasion of a vertebrae body
Unresectable or inoperable disease
Measurable disease
Suitable for radiotherapy, as deemed by the radiation oncologist
No scalene, supraclavicular, or contralateral hilar node involvement

Pleural effusion allowed provided it is transudate, cytologically negative, and non-bloody, and, according to the radiation oncologist, the tumor can be encompassed within a reasonable radiation field

Pleural effusion seen on chest CT scan, but not on chest x-ray, that is too small to tap is allowed
No exudative, bloody, or cytologically malignant effusions
No known brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
ANC ≥ 1,500/mm³
Platelet count ≥ 75,000/mm³
Total bilirubin ≤ 1.5 mg/dL
Creatinine normal

Alkaline phosphatase AND AST or ALT meeting 1 of the following criteria:

Alkaline phosphatase normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
Able to swallow oral medications
No peripheral neuropathy > grade 1
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to selenomethionine or agents formulated with Cremophor EL

No concurrent uncontrolled illness including, but not limited to, any of the following:

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Clinically significant cardiac arrhythmia
Psychiatric illness or social situations that would limit compliance with study requirements

No currently "active" second malignancy other than non-melanoma skin cancer

Patients are considered not to have an "active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

At least 2 weeks since prior formal exploratory thoracotomy (N2 node identified making patient ineligible for surgery)
No prior chemotherapy or radiotherapy for NSCLC
No prior taxanes or platinum drugs
No other concurrent investigational agents or anticancer therapy
No concurrent combination antiretroviral therapy for HIV-positive patients

No other concurrent chemotherapy or hormonal therapy, except for the following:

Steroids administered for adrenal failure or septic shock
Hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
Glucocorticosteroids administered as antiemetics

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00526890

Recruitment Status:

Terminated

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00526890

Recruitment Status:

Terminated

Sponsor:


Roswell Park Cancer Institute

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