Lung Cancer Clinical Trial
Official title:
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination With Radiation for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II, Multi-Center Trial
Verified date | October 2017 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 16 |
Est. completion date | September 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Grade 3-4 Esophagitis | During study treatment, up to 6 weeks | ||
Primary | Incidence of Grade 3-4 Pneumonitis | During study treatment, up to 6 weeks | ||
Primary | Incidence of Grade 3-4 Myelosuppression | During study treatment, up to 6 weeks | ||
Secondary | Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | 1 month post-treatment, then q 3 months x 4 | |
Secondary | Failure-free Survival | Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter. | ||
Secondary | Overall Survival | Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter | ||
Secondary | Selenium Level by Incidence of SAE | Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events. | Pre-treatment and every week for 6 weeks prior to chemotherapy. |
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