Small Cell Lung CancerPhase 2NCT01872416
A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer
A Phase 2 study testing Liposomal Doxorubicin Combined With ifosfamide in people with Small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
At present, there is no standard second-line treatment of refractory and relapsed SCLC, topotecan, gemcitabine, paclitaxel, irinotecan and drugs such as cyclophosphamide second-line treatment of small cell lung cancer currently being explored, Anthracycline antibiotics is a cell cycle non-specific anticancer drugs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Liposomal Doxorubicin Combined With ifosfamide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to May 2015
- 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
- Male or female patients >=18 years of age
- the histological diagnosis of small cell lung cancer;
- Patients who had first-line treatment failure or relapse after first-line therapy;
- enough tumor tissue specimens for molecular marker analysis;
- Measurable disease by RECIST criteria
- ECOG performance status of <=2.
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- Life expectancy of at least 3 months.
- Laboratory values as follows:: ANC ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; HB ≥ 90g/L; serum bilirubin ≤ 1.5 upper limit of normal (N); ALT/AST≤ 2N (in patients with liver metastases :ALT/AST≤ 5N) creatinine≤1.25 N;and clearance rate of creatinine ≥ 60mLl/min; proteinuria < 2+, or were detected in 24 hour urine protein, protein content is ≤1g
- Patient must be accessible for treatment and follow-up
- All patients must be able to understand the nature of the study and give written informed consent prior to study entry
Who cannot join
- mixed small cell lung cancer;
- patients had a previous diagnosis of malignant tumor;
- HIV infection;
- A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of > grade 2 per New York Heart Association (NYHA) criteria, myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
- patients had the motor or sensory neurons lesions/symptoms of NCI - CTC AE > 1;
- patients had serious active infections;
- patients were allergic to ifosfamide or liposomal doxorubicin
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
he First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120
Jianxing He, MD, +86-20-83062808, hejx@vip.163.com
Yalei Zhang, Master, +86-20-83062821, yayazhang2004@163.com
About this study
Official title: A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer: Single Center, Single-arm Study
At present, there is no standard second-line treatment of refractory and relapsed SCLC, topotecan, gemcitabine, paclitaxel, irinotecan and drugs such as cyclophosphamide second-line treatment of small cell lung cancer currently being explored, Anthracycline antibiotics is a cell cycle non-specific anticancer drugs could inhibit the synthesis of DNA, DNA and dependent RNA, its wide antitumor spectrum, widely used in malignant hematologic diseases and lung cancer and other solid tumors. Jacot W, et al evaluated epirubicin combined with ifosfamide (EI) for treatment of refractory and recurrent SCLC in 70 cases, the objective response rate (ORR) reached 21.4%, including 1 cases of complete remission, 10% other patients obtained stable disease (SD), all the patients had a median survival of 3.9 months, most (71%) patients with neutropenia, platelet count and anemia are also common, showed that EI treatment of refractory and relapsed SCLC is effectively controlled, toxicity.
In view of epirubicin combined with ifosfamide (EI) scheme is effective and safety in the treatment of refractory and relapsed SCLC, the investigators will use liposomal doxorubicin plus ifosfamide second-line treatment of refractory and relapsed small cell lung cancer, may obtain better tumor remission rate, improve the prognosis of the patients.
Read the detailed description
the investigators will evaluate the overall response rate (complete and partial responses) in first-line treatment failure or relapse after first-line therapy SCLC treated with Pegylated liposomal doxorubicin and ifosfamide We will evaluate the progression-free survival (PFS) and overall survival (OS) i in receiving first-line treatment failure or relapse after first-line therapy SCLC treated with Pegylated liposomal doxorubicin and ifosfamide
- Conditions
- Small Cell Lung Cancer
- Being tested
- Liposomal Doxorubicin Combined With ifosfamide
- Keywords
- Refractory and relapsed small cell lung cancer, Liposomal Doxorubicin, ifosfamide
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Doxorubicin Combined With ifosfamideDevice
Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer
| Study group | Role | What they receive |
|---|---|---|
| Refractory and relapsed SCLC | Experimental | Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer Receives: Device: Liposomal Doxorubicin Combined With ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
participants will be followed for the duration of hospital stay, an expected average of 5 months
Measured: From date of randomization until the date of progression, assessed up to 5 months
Secondary outcomes (1)
progression free survival(PFS）
Measured: From date of randomization until the date of progression, assessed up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- jianxing He, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872416
- Sponsor's protocol ID
- FAHG20120926A
- Other IDs
- FAHGuangzhou012
- Status last verified
- Jun 2013
- First submitted
- 17 May 2013
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Liposomal Doxorubicin Combined With Ifosfamide Second-line Treatment in Small Cell Lung Cancer: Single Center, Single-arm Study
- ClinicalTrials.gov ID
- NCT01872416
- Acronym / sponsor ID
- FAHG20120926A
- Conditions
- Small Cell Lung Cancer
- Keywords
- Refractory and relapsed small cell lung cancer, Liposomal Doxorubicin, ifosfamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 7 Jun 2013 (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.
At present, there is no standard second-line treatment of refractory and relapsed SCLC, topotecan, gemcitabine, paclitaxel, irinotecan and drugs such as cyclophosphamide second-line treatment of small cell lung cancer currently being explored, Anthracycline antibiotics is a cell cycle non-specific anticancer drugs could inhibit the synthesis of DNA, DNA and dependent RNA, its wide antitumor spectrum, widely used in malignant hematologic diseases and lung cancer and other solid tumors. Jacot W, et al evaluated epirubicin combined with ifosfamide (EI) for treatment of refractory and recurrent SCLC in 70 cases, the objective response rate (ORR) reached 21.4%, including 1 cases of complete remission, 10% other patients obtained stable disease (SD), all the patients had a median survival of 3.9 months, most (71%) patients with neutropenia, platelet count and anemia are also common, showed that EI treatment of refractory and relapsed SCLC is effectively controlled, toxicity.
In view of epirubicin combined with ifosfamide (EI) scheme is effective and safety in the treatment of refractory and relapsed SCLC, the investigators will use liposomal doxorubicin plus ifosfamide second-line treatment of refractory and relapsed small cell lung cancer, may obtain better tumor remission rate, improve the prognosis of the patients.
Detailed description
the investigators will evaluate the overall response rate (complete and partial responses) in first-line treatment failure or relapse after first-line therapy SCLC treated with Pegylated liposomal doxorubicin and ifosfamide We will evaluate the progression-free survival (PFS) and overall survival (OS) i in receiving first-line treatment failure or relapse after first-line therapy SCLC treated with Pegylated liposomal doxorubicin and ifosfamide
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractory and relapsed SCLC | Experimental | Device: Liposomal Doxorubicin Combined With ifosfamideLiposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients >=18 years of age
- the histological diagnosis of small cell lung cancer;
- Patients who had first-line treatment failure or relapse after first-line therapy;
- enough tumor tissue specimens for molecular marker analysis;
- Measurable disease by RECIST criteria
Key exclusion criteria (7 listed)
- mixed small cell lung cancer;
- patients had a previous diagnosis of malignant tumor;
- HIV infection;
- A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of > grade 2 per New York Heart Association (NYHA) criteria, myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
- patients had the motor or sensory neurons lesions/symptoms of NCI - CTC AE > 1;
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 |
|---|---|---|
| Liposomal Doxorubicin Combined With ifosfamideLiposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer | Device | Refractory and relapsed SCLC |
Primary outcome
objective response rate
Time frame: From date of randomization until the date of progression, assessed up to 5 months
participants will be followed for the duration of hospital stay, an expected average of 5 months
1 secondary outcome
progression free survival(PFS）
Time frame: From date of randomization until the date of progression, assessed up to 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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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.
jianxing He, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
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 Liposomal Doxorubicin Combined With ifosfamide in people with Small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Jun 2013. 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 China. 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?
Contact jianxing He, MD (+86-20-83062808, hejx@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: From date of randomization until the date of progression, assessed up to 5 months). 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 18 Jun 2013.