Lung CancerPhase 2NCT00526890
Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase 2 study testing selenomethionine, carboplatin and paclitaxel in people with Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- selenomethionine, carboplatin and paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
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
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.
Read the detailed 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.
- Conditions
- Lung Cancer
- Being tested
- selenomethionine, carboplatin, paclitaxel, laboratory biomarker analysis, radiation therapy
- Keywords
- squamous cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenosquamous cell lung cancer
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenomethionineDietary supplement
Oral Twice daily
carboplatinDrug
Weekly IV
paclitaxelDrug
Weekly IV
laboratory biomarker analysisOther
Correlative Study
radiation therapyRadiation
Undergoing radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| CPSR | Experimental | Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation Receives: Dietary Supplement: selenomethionine; Drug: carboplatin; Drug: paclitaxel; Other: laboratory biomarker analysis; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3-4 Esophagitis
Measured: During study treatment, up to 6 weeks
Incidence of Grade 3-4 Pneumonitis
Measured: During study treatment, up to 6 weeks
Incidence of Grade 3-4 Myelosuppression
Measured: During study treatment, up to 6 weeks
Secondary outcomes (4)
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.
Measured: 1 month post-treatment, then q 3 months x 4
Failure-free Survival
Measured: 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
Measured: 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
Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.
Measured: Pre-treatment and every week for 6 weeks prior to chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2006
- Primary completionAug 2010
- Study completionSep 2010
Why it stopped: lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Gomez, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526890
- Sponsor's protocol ID
- CDR0000562780
- Other IDs
- RPCI-I-65605
- Status last verified
- Oct 2017
- First submitted
- 7 Sep 2007
- Last updated
- 28 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00526890
- Acronym / sponsor ID
- CDR0000562780
- Conditions
- Lung Cancer
- Keywords
- squamous cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenosquamous cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of efficacy
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Posted 15 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPSR | Experimental | Dietary Supplement: selenomethionine, Drug: carboplatin, Drug: paclitaxel, Other: laboratory biomarker analysis, Radiation: radiation therapyConcurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selenomethionineOral Twice daily | Dietary supplement | CPSR |
| carboplatinWeekly IV | Drug | CPSR |
| paclitaxelWeekly IV | Drug | CPSR |
| laboratory biomarker analysisCorrelative Study | Other | CPSR |
| radiation therapyUndergoing radiation Therapy | Radiation | CPSR |
Primary outcome
Incidence of Grade 3-4 Esophagitis
Time frame: During study treatment, up to 6 weeks
Incidence of Grade 3-4 Pneumonitis
Time frame: During study treatment, up to 6 weeks
Incidence of Grade 3-4 Myelosuppression
Time frame: During study treatment, up to 6 weeks
4 secondary outcomes
Response Rate
Time frame: 1 month post-treatment, then q 3 months x 4
Failure-free Survival
Time frame: 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
Time frame: 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
Time frame: Pre-treatment and every week for 6 weeks prior to chemotherapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Gomez, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing selenomethionine, carboplatin and paclitaxel in people with Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3-4 Esophagitis (time frame: During study treatment, up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.