Lung CancerPhase 2NCT01024712
Paclitaxel, Carboplatin, and Gefitinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing carboplatin, gefitinib and paclitaxel in people with Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, gefitinib and paclitaxel
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- May 2009to not given
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- No squamous cell carcinoma
- Untreated Stage IIIB or IV disease not suitable for surgery or radiotherapy OR patients with postoperative recurrence who had never been treated by chemotherapy
- No history of smoking or light smoking (< 10 packs a year and smoking abatement ≥ 15 years)
- At least 1 measurable tumor mass (length > 1.5 cm and width > 1.0 cm)
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 2 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- ALT and AST ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤1.5 times ULN
- Serum creatinine normal
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignant tumors within the past year except for basal cell or squamous cell carcinoma of the skin, or in situ malignant cancer that has been completely resected
- No history of allergic reaction to any component of the drugs in this study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 1 month since prior investigational drugs or medical devices
- No prior chemotherapy or radiotherapy for this tumor
- No concurrent liposomal paclitaxel
- No other concurrent antitumor therapy (e.g., radiotherapy or surgical treatment)
- No other concurrent anticancer chemotherapy drugs or anticancer Chinese herbs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Yuankai Shi, MD, PhD, 86-10-137-0125-1865
About this study
Official title: Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel and carboplatin together with gefitinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and carboplatin together with gefitinib and to see how well it works in treating patients with Stage IIIB or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the efficacy, in terms of overall response, and safety of paclitaxel and carboplatin in combination with intermittent gefitinib in patients with advanced nonsquamous non-small cell lung cancer.
Secondary
- Determine the disease-control rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV on day 1, carboplatin IV on day 2, and oral gefitinib once daily on days 8-17. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with complete response or partial response may continue maintenance therapy comprising oral gefitinib once daily in the absence of disease progression or unacceptable toxicity.
Patients complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline, during study treatment, and after completion of study treatment for quality-of-life study.
After completion of study treatment, patients are followed every 2 months for 2 years and then every 4 months thereafter.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, gefitinib, paclitaxel, quality-of-life assessment
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
gefitinibDrug
paclitaxelDrug
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall-response rate
Secondary outcomes (5)
Disease-control rate
Safety
Quality of life
Progression-free survival
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Yuankai Shi, MD, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024712
- Sponsor's protocol ID
- CIH-CAMS-CHL-020
- Other IDs
- CDR0000643743
- Status last verified
- Dec 2009
- First submitted
- 2 Dec 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial
- ClinicalTrials.gov ID
- NCT01024712
- Acronym / sponsor ID
- CIH-CAMS-CHL-020
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- May 2009
- First posted
- 3 Dec 2009 (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.
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel and carboplatin together with gefitinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and carboplatin together with gefitinib and to see how well it works in treating patients with Stage IIIB or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the efficacy, in terms of overall response, and safety of paclitaxel and carboplatin in combination with intermittent gefitinib in patients with advanced nonsquamous non-small cell lung cancer.
Secondary
- Determine the disease-control rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV on day 1, carboplatin IV on day 2, and oral gefitinib once daily on days 8-17. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with complete response or partial response may continue maintenance therapy comprising oral gefitinib once daily in the absence of disease progression or unacceptable toxicity.
Patients complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline, during study treatment, and after completion of study treatment for quality-of-life study.
After completion of study treatment, patients are followed every 2 months for 2 years and then every 4 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carboplatin | Drug | – |
| gefitinib | Drug | – |
| paclitaxel | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Overall-response rate
5 secondary outcomes
Disease-control rate
Safety
Quality of life
Progression-free survival
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Yuankai Shi, MD, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 carboplatin, gefitinib and paclitaxel in people with Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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?
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 12 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall-response rate. 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 12 Aug 2013.