Non-small Cell Lung Cancer MetastaticPhase 2TAXIS01NCT01356303
Docetaxel Combined With Cisplatin as First Line in Patients With Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing cisplatin, docetaxel in people with Non-small Cell Lung Cancer Metastatic, run by National Guard Health Affairs at 1 site in Saudi Arabia.
Trial summary
This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical City, Riyadh. Sub-sites will be open for patient accrual in selected centers in the Kingdom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- cisplatin, docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2009to Aug 2016
- 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
- Histologically or cytologically proven non-small cell lung carcinoma
- Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural effusion.
- Patient should not be eligible for customization chemotherapy (if available at participating institutions).
- Having at least one measurable lesion
- Patient has life expectancy of 12 weeks or greater.
- Age > 18 years.
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- No prior systemic treatment for metastatic lung cancer. Adjuvant treatment given more than 1 year ago is acceptable.
- WHO performance status 0-2 (See Appendix III )
- Adequate organ function:
- Hematology: Neutrophils > 2 x 10 9 /L, platelets > 100 x 10 9 /L
- Hepatic function: Total bilirubin < 1.25 times the upper normal limits, ASAT (SGOT) < 2 times the upper normal limits
- Renal function: Creatinine < 1.5 mg/dL; if value is higher than upper normal limit but less than 2 mg/dL, the creatinine clearance should be > 60min/ml.
- Able to comply with scheduled follow-up and with management of toxicity
- Signed informed consent from patient or legal representative
- Negative urine pregnancy test (if indicated)
Who cannot join
- Pregnant or lactating women or women of childbearing potential using inadequate contraception.
- Uncontrolled brain metastatic disease. (CNS disease that is stable > 4 weeks after radiotherapy in lieu of steroids reduction is eligible).
- Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity Criteria Version 3
- Other serious illness or medical condition:
- Unstable cardiac disease requiring treatment
- History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures
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- Active uncontrolled infection
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
- Concurrent treatment with any other anti-cancer therapy
- Contraindication of steroid drug administration
- Past (up to 5 years) or concurrent history of other neoplasm except curatively treated non- melanoma skin cancer or in situ carcinoma of the cervix
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, 11426
About this study
Official title: A Phase II Study of Docetaxel Combined With Cisplatin as the First Line Chemotherapy in Patients With Metastatic Non-small Cell Lung Cancer
This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical City, Riyadh.
Sub-sites will be open for patient accrual in selected centers in the Kingdom.
Read the detailed description
The cisplatin/docetaxel is established standard in the first line management of metastatic non small cell lung cancer in the United States, Europe and Asia. However, the safety and efficacy of this regimen was not studied systematically in Middle Eastern population. The aim of this study is to study the efficacy and safety of this regimen in our patient population
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- cisplatin, docetaxel
- Keywords
- Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin, docetaxelDrug
All patients met the eligibility criteria will undergo treatment with chemotherapy.
Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of Dextrose 5% in Water or Normal Saline administered as a 1-hour intravenous infusion followed by cisplatin at dose of 75 mg/m2 administered as a 2-hour intravenous infusion every 3 weeks per cycle for totally 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin, Docetaxel | Experimental | Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of D5W or NS administered as a 1-hour intravenous infusion, followed by cisplatin at dose of 75 mg/m2administered as a 2-hour intravenous infusion every 3 weeks per cycle for 4-6 cycles Receives: Drug: cisplatin, docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Efficacy will be measured by calculating the following:
- Response rate using Response Evaluation Criteria for Solid Tumor criteria
- Time to Disease progression or Death
- Overall Survival
Measured: 3 years
Secondary outcomes (1)
Progression free survival, safety
- To determine progression free survival, median survival and 1 year survival of the studied population.
- To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 4 parameters to be collected for all patients who receive the study regimen which are:
- Adverse Events
- Laboratory Assessments
- Vital Signs
- Physical Examinations
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 startMar 2009
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: Difficulty in enrolling patients
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 Cancer MetastaticStudies 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
- 50 participants (estimated)
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
- NCT01356303
- Sponsor's protocol ID
- RC08/068
- Acronym
- TAXIS01
- Status last verified
- May 2016
- First submitted
- 19 Mar 2011
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Docetaxel Combined With Cisplatin as the First Line Chemotherapy in Patients With Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01356303
- Acronym / sponsor ID
- TAXIS01 / RC08/068
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- Lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulty in enrolling patients
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Guard Health AffairsOther government
- Study start
- Mar 2009
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- 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.
This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical City, Riyadh.
Sub-sites will be open for patient accrual in selected centers in the Kingdom.
Detailed description
The cisplatin/docetaxel is established standard in the first line management of metastatic non small cell lung cancer in the United States, Europe and Asia. However, the safety and efficacy of this regimen was not studied systematically in Middle Eastern population. The aim of this study is to study the efficacy and safety of this regimen in our patient population
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 | Experimental | Drug: cisplatin, docetaxelEach cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of D5W or NS administered as a 1-hour intravenous infusion, followed by cisplatin at dose of 75 mg/m2administered as a 2-hour intravenous infusion every 3 weeks per cycle for 4-6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically proven non-small cell lung carcinoma
- Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural effusion.
- Patient should not be eligible for customization chemotherapy (if available at participating institutions).
- Having at least one measurable lesion
- Patient has life expectancy of 12 weeks or greater.
Key exclusion criteria (11 listed)
- Pregnant or lactating women or women of childbearing potential using inadequate contraception.
- Uncontrolled brain metastatic disease. (CNS disease that is stable > 4 weeks after radiotherapy in lieu of steroids reduction is eligible).
- Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity Criteria Version 3
- Other serious illness or medical condition:
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
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, docetaxelAll patients met the eligibility criteria will undergo treatment with chemotherapy. Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of Dextrose 5% in Water or Normal Saline administered as a 1-hour intravenous infusion followed by cisplatin at dose of 75 mg/m2 administered as a 2-hour intravenous infusion every 3 weeks per cycle for totally 4-6 cycles. | Drug | Cisplatin, Docetaxel |
Primary outcome
Efficacy
Time frame: 3 years
Efficacy will be measured by calculating the following: * Response rate using Response Evaluation Criteria for Solid Tumor criteria * Time to Disease progression or Death * Overall Survival
1 secondary outcome
Progression free survival, safety
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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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, docetaxel in people with Non-small Cell Lung Cancer Metastatic, 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 15 inclusion and 11 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: paused, as of the sponsor's last update on 13 May 2016. 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?
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 (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 13 May 2016.