Non-small Cell Lung CancerPhase 2NCT00173888
Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Docetaxel, Cisplatin and Gemcitabine, Cisplatin in people with Non-small Cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Docetaxel, Cisplatin and Gemcitabine, Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2003to Nov 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic diagnosis of stage IIIB/IV NSCLC, no prior chemotherapy
- Age > 18 years and < 75 years
- WHO PS: 0,1
- Unidimensional or bi-dimensional measurable disease
- Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 10g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL; except in presence of only bone metastasis and in the absence of any liver disorders
- Creatinine < 1 UNL, and creatinine clearance should be > 60 ml/min.
- Life expectancy > 12 weeks
Who cannot join
- Pregnant, or lactating patients
- Known clinical brain or leptomeningeal involvement
- Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by NCIC-CTG criteria
- CHF, angina or arrhythmias
- History of significant neurological or psychiatric disorders
- Active uncontrolled infection
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- Contraindication for the use of corticosteroids
- Concurrent treatment with other experimental drugs within 30 days prior to study entry
- Concurrent treatment with any other anti-cancer therapy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Oncology, National Taiwan University Hospital
Taipei
About this study
Official title: A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer
The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。
Read the detailed description
Lung cancer is the leading cause of cancer death in men and women worldwide. Shifting trends in the incidence of lung cancer closely follow the patterns of cigarette smoking, although other carcinogens have been implicated. Despite intensive treatment over the past several decades, the 5-year lung-cancer survival rate remains a dismal 8-14%.
Chemotherapy is the primary therapy to patients with stage IIIB/IV disease, and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage IV NSCLC. In the late 1970s and 1980s, studies were conducted using combinations of agents. Outcomes were improved and these agents were eventually incorporated into clinical practice.
Weekly docetaxel is being studied in combination with other commonly used NSCLC chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. These combinations are being studied in both first- and second-line settings. Second line chemotherapy with docetaxel may affect survival (TAX 318, 1 year survival 37% vs. 11%). However, the optimal sequence of chemotherapy was rarely explored. Weekly docetaxel may offer better tolerability vs. 3-weekly schedule when combining docetaxel to cisplatin. Based upon these studied, we choose weekly docetaxel in combination with cisplatin as our regimen. We expected the regimen would be effective and well tolerated.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Docetaxel, Cisplatin, Gemcitabine, Cisplatin
- Keywords
- Combination, Chemotherapy,non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, CisplatinDrug
docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15
Gemcitabine, CisplatinDrug
gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Docetaxel, Cisplatin |
| B | Active comparator | Not described Receives: Drug: Gemcitabine, Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens.
Measured: 2003~2009
Secondary outcomes (1)
To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response
Measured: 2003~2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionNov 2012
- Study completionNov 2012
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.
- More trials run by National Taiwan University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Hsin Yang, M.D.,Ph.D., Principal investigator, Department of Oncology , National Taiwan University HospitalAnn-Lii Cheng, M.D.,Ph.D., Study chair, Department of Oncology , National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173888
- Sponsor's protocol ID
- 920303
- Status last verified
- Dec 2012
- First submitted
- 8 Sep 2005
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00173888
- Acronym / sponsor ID
- 920303
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Combination, Chemotherapy,non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Sep 2005 (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 purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。
Detailed description
Lung cancer is the leading cause of cancer death in men and women worldwide. Shifting trends in the incidence of lung cancer closely follow the patterns of cigarette smoking, although other carcinogens have been implicated. Despite intensive treatment over the past several decades, the 5-year lung-cancer survival rate remains a dismal 8-14%.
Chemotherapy is the primary therapy to patients with stage IIIB/IV disease, and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage IV NSCLC. In the late 1970s and 1980s, studies were conducted using combinations of agents. Outcomes were improved and these agents were eventually incorporated into clinical practice.
Weekly docetaxel is being studied in combination with other commonly used NSCLC chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. These combinations are being studied in both first- and second-line settings. Second line chemotherapy with docetaxel may affect survival (TAX 318, 1 year survival 37% vs. 11%). However, the optimal sequence of chemotherapy was rarely explored. Weekly docetaxel may offer better tolerability vs. 3-weekly schedule when combining docetaxel to cisplatin. Based upon these studied, we choose weekly docetaxel in combination with cisplatin as our regimen. We expected the regimen would be effective and well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Docetaxel, Cisplatin |
| B | Active comparator | Drug: Gemcitabine, Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic or cytologic diagnosis of stage IIIB/IV NSCLC, no prior chemotherapy
- Age > 18 years and < 75 years
- WHO PS: 0,1
- Unidimensional or bi-dimensional measurable disease
- Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 10g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL; except in presence of only bone metastasis and in the absence of any liver disorders
Key exclusion criteria (9 listed)
- Pregnant, or lactating patients
- Known clinical brain or leptomeningeal involvement
- Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by NCIC-CTG criteria
- CHF, angina or arrhythmias
- History of significant neurological or psychiatric disorders
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 |
|---|---|---|
| Docetaxel, Cisplatindocetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15 | Drug | A |
| Gemcitabine, Cisplatingemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15 | Drug | B |
Primary outcome
The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens.
Time frame: 2003~2009
1 secondary outcome
To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response
Time frame: 2003~2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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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.
Chih-Hsin Yang, M.D.,Ph.D. principal investigator
Department of Oncology , National Taiwan University Hospital
Ann-Lii Cheng, M.D.,Ph.D. study chair
Department of Oncology , National Taiwan University Hospital
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 Docetaxel, Cisplatin and Gemcitabine, Cisplatin in people with Non-small Cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 6 Dec 2012. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens. (time frame: 2003~2009). 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 6 Dec 2012.