Carcinoma, Non-Small-Cell LungPhase 2NCT01192230
Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
A Phase 2 study testing Endostatins and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Endostatins and Docetaxel
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Dec 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
- ≥ 18 years old
- patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
- At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
- have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
- ECOG 0-2
Show all 17Show fewer
- Expected life time longer than 3 months
- Normal laboratory values:
- leucocyte≥ 4×109/L
- neutrophil≥ 1.5×109/L
- platelet≥90×109/L
- Hemoglobin≥ 9g/L
- ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)
- serum creatinine<1.5 mg/dl
- bilirubin <1.5×ULN
- No allergy to biological drug
- Sign the consent forms
Who cannot join
- Patients who have previously received Docetaxel or anti-VEGF inhibitors
- Severe symptomatic heart disease
- Female patients during their pregnant and lactation period, or patients without contraception
- Severe uncontrolled infection
- Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
- Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ
- Patients have accepted other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Jianhua Chang, MD,PhD, 13916619284, changjianhua@hotmail.com
About this study
Official title: A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Endostatins, Docetaxel
- Keywords
- Objective response rate, Disease control rate, Disease free survival, Overall survival, Quality of Live, Nonsmall cell lung cancer, toxicity
- 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.
EndostatinsDrug
7.5mg/m2 qd *14d,q3w
DocetaxelDrug
75mg/m2 D1, q3w,4-6cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: six weeks
Progression free survival
Measured: six weeks
Overall survival
Measured: three months
Secondary outcomes (1)
Quality of Life
EORTC QLQ-C30(v3.0)
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jianhua Chang, MD,PhD, Principal investigator, Fudan University affiliated cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192230
- Sponsor's protocol ID
- EndoDocNSCLC
- Status last verified
- Aug 2010
- First submitted
- 4 Aug 2010
- Last updated
- 16 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01192230
- Acronym / sponsor ID
- EndoDocNSCLC
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Objective response rate, Disease control rate, Disease free survival, Overall survival, Quality of Live, Nonsmall cell lung cancer, toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 1 Sep 2010 (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 examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
- ≥ 18 years old
- patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
- At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
- have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
Key exclusion criteria (7 listed)
- Patients who have previously received Docetaxel or anti-VEGF inhibitors
- Severe symptomatic heart disease
- Female patients during their pregnant and lactation period, or patients without contraception
- Severe uncontrolled infection
- Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
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 |
|---|---|---|
| Endostatins7.5mg/m2 qd *14d,q3w | Drug | – |
| Docetaxel75mg/m2 D1, q3w,4-6cycles | Drug | – |
Primary outcome
Response rate
Time frame: six weeks
Progression free survival
Time frame: six weeks
Overall survival
Time frame: three months
1 secondary outcome
Quality of Life
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
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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.
Jianhua Chang, MD,PhD principal investigator
Fudan University affiliated cancer 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 Endostatins and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Fudan 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 17 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 16 Sep 2010. 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 Jianhua Chang, MD,PhD (13916619284, changjianhua@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: six weeks). The study lists 3 primary outcomes in all. 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 16 Sep 2010.