Non-Small Cell Lung CancerPhase 2CustomizingNCT01356368
Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Cisplatin, Gemzar, Docetaxel, Alimta in people with Non-Small Cell Lung Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.
Trial summary
The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Cisplatin, Gemzar, Docetaxel, Alimta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2010to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV
- Having adequate tissue sample to perform the markers testing
- Age ≥ 18 years
- No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable)
- No other concurrent cancer treatment
- Performance status of 0- 2 per ECOG scale (Appendix II)
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- Adequate laboratory values as follows as follows:
- Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤ 1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal level Serum creatinine ≤ 1.5 X institutional upper normal level
- Presence of measurable disease
Who cannot join
- Prior systemic treatment for lung cancer
- History of hypersensitivity to drugs used
- Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer
- Medical illness that puts the patient at significant risk per investigator's discretion
- Uncontrolled CNS disease. Patients with CNS metastatic disease treated with radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after the treatment initiation without increase dose of steroids
- Positive pregnancy test or refusal to use contraception during treatment. (Gynecology consultant for contraception)
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh
About this study
Official title: A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers
The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole.
The results of this pilot study will help in designing more definitive trials in our patient population.
Read the detailed description
The treatment of advanced NSCLC cancer includes various chemotherapies with equivalent regimens that have reached a therapeutic plateau. The selection of these regimens is completely empirical and physician dependent. Potential predictors of specific agent efficacy exist in the form of tumor molecular markers that are a reflection of the individual's genetic make up. Thus our study aims at utilizing these markers to more efficiently select the regimen in order to maximize the benefit to the patients rather than using empiric approaches. Fortunately, each of our selected regimens contains active and well-studied agents in the treatment of lung cancer (Table 1). This pilot study will help us determine the benefit, and safety of this approach (not individual regimen). The study is not to compare individual regimens but it aims at testing the whole concept of customization of chemotherapy based on molecular markers to help us in the future at selecting regimens based on these markers and not empirically. The results then will be used to determine more definitive future studies.
Furthermore, circulating tumor cells in the blood represent the future distant metastases that result in disease progression to incurable stages. The circulating tumor cells have the ability to cross into vessels, travel in circulation, and exit the vessels into tissues where they have the capability to grow. Therefore, these cells may express different biological and molecular features from the stationary cells in the primary tumors. Therefore, exploiting these circulating tumor cells for augmenting treatment approaches is of vital importance and utility.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Cisplatin, Gemzar, Docetaxel, Alimta
- Keywords
- Lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin, Gemzar, Docetaxel, AlimtaDrug
Patients will be assigned to treatment according to the molecular biological results which will analyze excision repair cross-complementing (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and beta-tubulin genes in primary tumor cells which are present in tissues and peripheral blood.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin,Docetaxel,Gemzar, Premetrexed | Experimental | Patients will receive treatment for up to six cycles of the assigned regimen unless there is disease progression or unacceptable toxicities. After treatment, the patients will be seen every 2 months for the first year, then every 3 months for the second year and every 6 months afterwards. Receives: Drug: Cisplatin, Gemzar, Docetaxel, Alimta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Safety
- Efficacy is measured by:
- overall response rate (partial response and complete response) using RECIST Criteria
- time to disease progression (TTP)
- progression free survival (PFS)
- overall survival (OS)
- To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 5 parameters to be collected for all patients who receive the study regimen which are:
- Adverse Events
- Laboratory Assessments
- Vital Signs
- Physical Examinations
- ECG
Measured: 3 years
Secondary outcomes (1)
Tumor marker
- The molecular characteristics of circulating tumor cells harvested from peripheral blood
- Correlation between the markers of circulating tumor cells and primary tumor.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: slow accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Guard Health Affairs
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Abdulrahman Jazieh, MD/MPH, Principal investigator, King Abdul Aziz Medical City for National Guard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356368
- Sponsor's protocol ID
- RC09/095
- Acronym
- Customizing
- Status last verified
- Jan 2014
- First submitted
- 19 Mar 2011
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers
- ClinicalTrials.gov ID
- NCT01356368
- Acronym / sponsor ID
- Customizing / RC09/095
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual rate
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Guard Health AffairsOther government
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole.
The results of this pilot study will help in designing more definitive trials in our patient population.
Detailed description
The treatment of advanced NSCLC cancer includes various chemotherapies with equivalent regimens that have reached a therapeutic plateau. The selection of these regimens is completely empirical and physician dependent. Potential predictors of specific agent efficacy exist in the form of tumor molecular markers that are a reflection of the individual's genetic make up. Thus our study aims at utilizing these markers to more efficiently select the regimen in order to maximize the benefit to the patients rather than using empiric approaches. Fortunately, each of our selected regimens contains active and well-studied agents in the treatment of lung cancer (Table 1). This pilot study will help us determine the benefit, and safety of this approach (not individual regimen). The study is not to compare individual regimens but it aims at testing the whole concept of customization of chemotherapy based on molecular markers to help us in the future at selecting regimens based on these markers and not empirically. The results then will be used to determine more definitive future studies.
Furthermore, circulating tumor cells in the blood represent the future distant metastases that result in disease progression to incurable stages. The circulating tumor cells have the ability to cross into vessels, travel in circulation, and exit the vessels into tissues where they have the capability to grow. Therefore, these cells may express different biological and molecular features from the stationary cells in the primary tumors. Therefore, exploiting these circulating tumor cells for augmenting treatment approaches is of vital importance and utility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin,Docetaxel,Gemzar, Premetrexed | Experimental | Drug: Cisplatin, Gemzar, Docetaxel, AlimtaPatients will receive treatment for up to six cycles of the assigned regimen unless there is disease progression or unacceptable toxicities. After treatment, the patients will be seen every 2 months for the first year, then every 3 months for the second year and every 6 months afterwards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV
- Having adequate tissue sample to perform the markers testing
- Age ≥ 18 years
- No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable)
- No other concurrent cancer treatment
Key exclusion criteria (6 listed)
- Prior systemic treatment for lung cancer
- History of hypersensitivity to drugs used
- Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer
- Medical illness that puts the patient at significant risk per investigator's discretion
- Uncontrolled CNS disease. Patients with CNS metastatic disease treated with radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after the treatment initiation without increase dose of steroids
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 |
|---|---|---|
| Cisplatin, Gemzar, Docetaxel, AlimtaPatients will be assigned to treatment according to the molecular biological results which will analyze excision repair cross-complementing (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and beta-tubulin genes in primary tumor cells which are present in tissues and peripheral blood. | Drug | Cisplatin,Docetaxel,Gemzar, Premetrexed |
Primary outcome
Efficacy and Safety
Time frame: 3 years
1. Efficacy is measured by: * overall response rate (partial response and complete response) using RECIST Criteria * time to disease progression (TTP) * progression free survival (PFS) * overall survival (OS) 2. To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 5 parameters to be collected for all patients who receive the study regimen which are: * Adverse Events * Laboratory Assessments * Vital Signs * Physical Examinations * ECG
1 secondary outcome
Tumor marker
Time frame: 3 years
Results and safety
The study was stopped early (reason given: slow accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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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.
Abdulrahman Jazieh, MD/MPH principal investigator
King Abdul Aziz Medical City for National Guard
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 Cisplatin, Gemzar, Docetaxel, Alimta in people with Non-Small Cell Lung Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. 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 22 Jan 2014. 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 Saudi Arabia. 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?
The study was stopped early (reason given: slow accrual rate). Results are not available in the source record.
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?
Efficacy and Safety (time frame: 3 years). 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 22 Jan 2014.