- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00526890
Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
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
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
|
Korrelativ studie
Oral Twice daily
Weekly IV
Weekly IV
Undergoing radiation Therapy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incidence of Grade 3-4 Esophagitis
Tidsramme: During study treatment, up to 6 weeks
|
During study treatment, up to 6 weeks
|
Incidence of Grade 3-4 Pneumonitis
Tidsramme: During study treatment, up to 6 weeks
|
During study treatment, up to 6 weeks
|
Incidence of Grade 3-4 Myelosuppression
Tidsramme: During study treatment, up to 6 weeks
|
During study treatment, up to 6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Response Rate
Tidsramme: 1 month post-treatment, then q 3 months x 4
|
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
|
Failure-free Survival
Tidsramme: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.
|
Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.
|
|
Overall Survival
Tidsramme: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter
|
Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter
|
|
Selenium Level by Incidence of SAE
Tidsramme: Pre-treatment and every week for 6 weeks prior to chemotherapy.
|
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jorge Gomez, MD, Roswell Park Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Beskyttende agenter
- Antineoplastiske midler, fytogene
- Sporelementer
- Mikronæringsstoffer
- Antioksidanter
- Karboplatin
- Paklitaksel
- Selen
Andre studie-ID-numre
- CDR0000562780
- RPCI-I-65605
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