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

Roswell Park Comprehensive Cancer Center

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Other: laboratory biomarker analysis

Dietary Supplement: selenomethionine

Radiation: radiation therapy

Drug: carboplatin

Drug: paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00526890

CDR0000562780

RPCI-I-65605

Details and patient eligibility

About

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.

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.

Enrollment

16 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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