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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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

Other trials in United States

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 groups in NCT00526890
Study groupRoleWhat they receive
CPSRExperimentalConcurrent 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.

  1. Incidence of Grade 3-4 Esophagitis

    Measured: During study treatment, up to 6 weeks

  2. Incidence of Grade 3-4 Pneumonitis

    Measured: During study treatment, up to 6 weeks

  3. Incidence of Grade 3-4 Myelosuppression

    Measured: During study treatment, up to 6 weeks

Secondary outcomes (4)
  1. 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

  2. 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.

  3. 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

  4. 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.

  1. First posted10 Sep 2007 (estimated)
  2. Study startOct 2006
  3. Primary completionAug 2010
  4. Study completionSep 2010

Why it stopped: lack of efficacy

Resources

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)
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
Data monitoring committee
Yes

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.

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