ToxicityPhase 2NCT01192243
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
A Phase 2 study testing Gefitinib, Pemetrexed and Cisplatin or carboplatin in people with Toxicity and Non-small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Toxicity, Non-small Cell Lung Cancer
- What is being tested?
- Gefitinib, Pemetrexed and Cisplatin or carboplatin
- Type of treatment
- Injection or infusion
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Dec 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 70 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 IV non-small cell lung cancer
- Age from 18 to 70 years old
- At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
- ECOG 0-1
- Expected life time longer than 12 weeks
- Normal laboratory values:
- leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis)
Who cannot join
- Patients have not used drugs according to protocol
- Patients were allergic to pemetrexed or cisplatin
- Patients received radiotherapy or other biological treatment 4 weeks before the trial
- Uncontrolled hydrothorax or hydropericardium
- neuropathy toxicity ≥ CTC 3
- Severe symptomatic heart disease
Show all 12Show fewer
- Active upper gastrointestinal ulcer or digestive disfunction
- Severe infection or metabolic disfunction
- Patients with other malignant tumor
- Uncontrolled brain metastases
- Patients have accepted other clinical trials
- Female patients during their pregnant and lactation period, or patients without contraception
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: Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).
- Conditions
- Toxicity, Non-small Cell Lung Cancer
- Being tested
- Gefitinib, Pemetrexed, Cisplatin or carboplatin
- Keywords
- Objective response rate, Time to Progression, Quality of Live
- 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.
GefitinibDrug
250mg qd po d3-16
PemetrexedDrug
500mg/m2 venous infusion,D1,q3w
Cisplatin or carboplatinDrug
Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: six weeks
Secondary outcomes (3)
Number of Participants with Adverse Events
according to NCI CTC V3.0
Measured: six weeks
Progression free survival
Measured: six weeks
quality of life
according to FACT-LCS scores
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 startDec 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 ToxicityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 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
- NCT01192243
- Sponsor's protocol ID
- Iressa combined with Pem/Cis
- Status last verified
- Sep 2010
- First submitted
- 4 Aug 2010
- Last updated
- 3 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
- ClinicalTrials.gov ID
- NCT01192243
- Acronym / sponsor ID
- Iressa combined with Pem/Cis
- Conditions
- Toxicity, Non-small Cell Lung Cancer
- Keywords
- Objective response rate, Time to Progression, Quality of Live
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 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 gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
- Age from 18 to 70 years old
- At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
- ECOG 0-1
- Expected life time longer than 12 weeks
Key exclusion criteria (12 listed)
- Patients have not used drugs according to protocol
- Patients were allergic to pemetrexed or cisplatin
- Patients received radiotherapy or other biological treatment 4 weeks before the trial
- Uncontrolled hydrothorax or hydropericardium
- neuropathy toxicity ≥ CTC 3
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 |
|---|---|---|
| Gefitinib250mg qd po d3-16 | Drug | – |
| Pemetrexed500mg/m2 venous infusion,D1,q3w | Drug | – |
| Cisplatin or carboplatinCisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w | Drug | – |
Primary outcome
response rate
Time frame: six weeks
3 secondary outcomes
Number of Participants with Adverse Events
Time frame: six weeks
Progression free survival
Time frame: six weeks
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 3 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 Gefitinib, Pemetrexed and Cisplatin or carboplatin in people with Toxicity and Non-small Cell Lung Cancer, 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 7 inclusion and 12 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 3 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). 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 3 Sep 2010; AzTrials last refreshed its copy on 7 Nov 2026.