Non-small-cell Lung CancerPhase 4NCT01442909
Pemetrexed Followed by Docetaxel or in Reverse Sequence
A Phase 4 study testing Docetaxel and pemetrexed in people with Non-small-cell Lung Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Both pemetrexed and docetaxel have been reported to have similar activity against non-small cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III study. However, no study showed different toxicity and efficacy profiles within individual patients. 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?
- Docetaxel and pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2008to Sep 2009
- Phase
- Phase 4
- 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 confirmed non-small cell bronchogenic carcinoma, inoperable stage IIIB or IV
- aged 18 years or older
- failed previous platinum-based chemotherapy
- presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥ 20 mm with conventional CT or ≥ 10 mm with spiral CT scan
- performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
- white blood cell (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 10 mg / dl
Show all 10Show fewer
- serum creatinine level 2.0 mg/dL or lower
- serum bilirubin less than 1.5 times the upper limit of normal range (ULN)
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 times the ULN (less than 5 times the ULN in liver metastases)
- written informed consent to participate in the trial In addition, in female patient with childbearing potential, either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device [IUD], birth control pills, or barrier device) during and for three months after trial. Patients who previously treated by surgery are needed to demonstrate progressive disease before entering the study.
Who cannot join
- Active infection (at the discretion of the investigator).
- Active central nervous system (CNS) metastases.
- Breast feeding.
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Use of any investigational agent in the month before enrollment into the study.
- Concomitant myelosuppressive radiotherapy to target lesion, chemotherapy, hormonal therapy, or immunotherapy will not be allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Randomized Trial of Pemetrexed Followed by Docetaxel or in Reverse Sequence in Non-small-cell Lung Cancer Patients Failed Previous Chemotherapy
Both pemetrexed and docetaxel have been reported to have similar activity against non-small cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III study. However, no study showed different toxicity and efficacy profiles within individual patients. Present phase II randomized clinical trial is designed to answer these questions, with addition of information about whether or not sequential therapy can prolong disease-free and overall survival.
Read the detailed description
Docetaxel was the first third-generation anti-cancer drug found to have activity in second-line chemotherapy for NSCLC, with a prolongation of patient survival in phase III randomized trials comparing docetaxel with vinorelbine or ifosfamide, or with the best supportive care, for NSCLC patients who have failed previous chemotherapy; thus, it has been recommended for the second-line treatment of NSCLC. Four years after these trials, pemetrexed showed similar activity with less toxicity, when compared with docetaxel treatment in a phase III randomized trial of NSCLC patients previously treated with chemotherapy.
Pemetrexed is a multitargeted antifolate which exhibits clinical activity in a variety of solid tumors, especially malignant mesothelioma and NSCLC. It inhibits thymidylate synthase, dihydrofolate reductase and glycinamide ribonucleotide formyl transferase. Pemetrexed has confirmed activity against previously chemotherapy-treated NSCLC and has a better toxicity profile than docetaxel, in which study docetaxel dosage used was 75 mg/m2 intravenous infusion (IV) every 3 weeks. However, docetaxel dosage used in Japan and Taiwan is usually 60 mg/m2 every 3 weeks.
Whether or not toxicity profiles of these two different drugs in same individual patients is similar to findings of patients who received specific drug only is unknown, so is unknown of toxicity profiles of docetaxel 60 mg/m2 every 3 weeks comparing alimta 500 mg/m2 every 3 weeks. Present phase II randomized clinical trial is designed to answer these questions, with addition of information about whether or not sequential therapy can prolong disease-free and overall survival.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- Docetaxel and pemetrexed
- Keywords
- lung cancer, docetaxel, pemetrexed
- 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.
Docetaxel and pemetrexedDrug
Also called taxotere, alimta
docetaxel 60mg/m2 every 3 weeks for 4 cycles followed by pemetrexed 500mg/m2 every 3 weeks for 4 cycles; or in reverse sequence.
| Study group | Role | What they receive |
|---|---|---|
| D followed by P | Active comparator | Docetaxel 60 mg/m2 intravenous infusion (IV) day 1 every 3 weeks for 4-6 cycles (stable disease up to 4 cycles, partial or complete response up to 6 cycles), followed by pemetrexed 500 mg/m2 IV day 1 every 3 weeks for 4-6 cycles (stable disease up to 4 cycles, partial or complete response up to 6 cycles). Receives: Drug: Docetaxel and pemetrexed |
| P followed by D | Active comparator | Pemetrexed treatment followed by docetael (in reverse sequence of Arm "D followed by P" Receives: Drug: Docetaxel and pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade III or IV leukopenia during treatment
Measured: one year
Secondary outcomes (1)
progression-free survival
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionSep 2009
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 Taipei Veterans General Hospital, TaiwanThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yuh-Min Chen, MD, PhD., Principal investigator, Chest Department, Taipei VGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442909
- Sponsor's protocol ID
- 97-02-09
- Status last verified
- Sep 2011
- First submitted
- 25 May 2008
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Randomized Trial of Pemetrexed Followed by Docetaxel or in Reverse Sequence in Non-small-cell Lung Cancer Patients Failed Previous Chemotherapy
- ClinicalTrials.gov ID
- NCT01442909
- Acronym / sponsor ID
- 97-02-09
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- lung cancer, docetaxel, pemetrexed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 Sep 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.
Both pemetrexed and docetaxel have been reported to have similar activity against non-small cell lung cancer (NSCLC) who failed previous chemotherapy in a large randomized phase III study. However, no study showed different toxicity and efficacy profiles within individual patients. Present phase II randomized clinical trial is designed to answer these questions, with addition of information about whether or not sequential therapy can prolong disease-free and overall survival.
Detailed description
Docetaxel was the first third-generation anti-cancer drug found to have activity in second-line chemotherapy for NSCLC, with a prolongation of patient survival in phase III randomized trials comparing docetaxel with vinorelbine or ifosfamide, or with the best supportive care, for NSCLC patients who have failed previous chemotherapy; thus, it has been recommended for the second-line treatment of NSCLC. Four years after these trials, pemetrexed showed similar activity with less toxicity, when compared with docetaxel treatment in a phase III randomized trial of NSCLC patients previously treated with chemotherapy.
Pemetrexed is a multitargeted antifolate which exhibits clinical activity in a variety of solid tumors, especially malignant mesothelioma and NSCLC. It inhibits thymidylate synthase, dihydrofolate reductase and glycinamide ribonucleotide formyl transferase. Pemetrexed has confirmed activity against previously chemotherapy-treated NSCLC and has a better toxicity profile than docetaxel, in which study docetaxel dosage used was 75 mg/m2 intravenous infusion (IV) every 3 weeks. However, docetaxel dosage used in Japan and Taiwan is usually 60 mg/m2 every 3 weeks.
Whether or not toxicity profiles of these two different drugs in same individual patients is similar to findings of patients who received specific drug only is unknown, so is unknown of toxicity profiles of docetaxel 60 mg/m2 every 3 weeks comparing alimta 500 mg/m2 every 3 weeks. Present phase II randomized clinical trial is designed to answer these questions, with addition of information about whether or not sequential therapy can prolong disease-free and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D followed by P | Active comparator | Drug: Docetaxel and pemetrexedDocetaxel 60 mg/m2 intravenous infusion (IV) day 1 every 3 weeks for 4-6 cycles (stable disease up to 4 cycles, partial or complete response up to 6 cycles), followed by pemetrexed 500 mg/m2 IV day 1 every 3 weeks for 4-6 cycles (stable disease up to 4 cycles, partial or complete response up to 6 cycles). |
| P followed by D | Active comparator | Drug: Docetaxel and pemetrexedPemetrexed treatment followed by docetael (in reverse sequence of Arm "D followed by P" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically or cytologically confirmed non-small cell bronchogenic carcinoma, inoperable stage IIIB or IV
- aged 18 years or older
- failed previous platinum-based chemotherapy
- presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥ 20 mm with conventional CT or ≥ 10 mm with spiral CT scan
- performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
Key exclusion criteria (6 listed)
- Active infection (at the discretion of the investigator).
- Active central nervous system (CNS) metastases.
- Breast feeding.
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Use of any investigational agent in the month before enrollment into the study.
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 and pemetrexedAlso: taxotere, alimtadocetaxel 60mg/m2 every 3 weeks for 4 cycles followed by pemetrexed 500mg/m2 every 3 weeks for 4 cycles; or in reverse sequence. | Drug | D followed by P, P followed by D |
Primary outcome
Incidence of grade III or IV leukopenia during treatment
Time frame: one year
1 secondary outcome
progression-free survival
Time frame: one year
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 29 Sep 2011.
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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.
Yuh-Min Chen, MD, PhD. principal investigator
Chest Department, Taipei VGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Docetaxel and pemetrexed in people with Non-small-cell Lung Cancer, run by Taipei Veterans General Hospital, Taiwan 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 10 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: finished, as of the sponsor's last update on 29 Sep 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of grade III or IV leukopenia during treatment (time frame: one year). 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 29 Sep 2011.