Non Small Cell Lung CancerPhase 2PRIDENCT01196234
Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Paclitaxel/Carboplatin/Gefitinib and Paclitaxel/Carboplatin in people with Non Small Cell Lung Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations. 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?
- Paclitaxel/Carboplatin/Gefitinib and Paclitaxel/Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Dec 2012
- 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
- More than 18 years of age
- Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
- At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
- ECOG PS 0-2
- At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
- Patients must have adequate hematologic, renal and liver function as defined by Hb > 9g/dL, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dL, and AST (SGOT) and/or ALT (SGPT) < 5 x UNL (upper normal limit).
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Written and voluntary informed consent understood, signed and dated.
Who cannot join
- Patients with tumor harboring EGFR mutation.
- Prior systemic therapy for NSCLC
- Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study.
- Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
- Major surgery within 3 weeks prior to study enrollment.
- Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
- Severe medical illness or active infection that would impair the ability to receive gefitinib.
- Pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study
This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations.
Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.
Read the detailed description
A randomized phase II trial that compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with NSCLC without EGFR mutations. While previous studies with cytotoxic agents and gefitinib failed to show any benefit, we altered the schedule of administration in hopes to gain synergy between agents.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Paclitaxel/Carboplatin/Gefitinib, Paclitaxel/Carboplatin
- 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.
Paclitaxel/Carboplatin/GefitinibDrug
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15
Paclitaxel/CarboplatinDrug
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel/Carboplatin/Gefitinib | Experimental | Paclitaxel/Carboplatin/Gefitinib Receives: Drug: Paclitaxel/Carboplatin/Gefitinib |
| Paclitaxel/Carboplatin | Active comparator | Paclitaxel/Carboplatin Receives: Drug: Paclitaxel/Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: average 6 months
Secondary outcomes (2)
progression free survival
Measured: average 2 years
overall survival
Measured: average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Sang-We Kim, Asan Medical Center
- Investigators
- Sang-We Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196234
- Sponsor's protocol ID
- AMC 2009-0677
- Acronym
- PRIDE
- Status last verified
- Jan 2013
- First submitted
- 9 Aug 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi YJ, Lee DH, Choi CM, Lee JS, Lee SJ, Ahn JH, Kim SW. Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naive non-small cell lung cancer in a clinically selected population excluding patients with non-smoking adenocarcinoma or mutated EGFR. BMC Cancer. 2015 Oct 22;15:763. doi: 10.1186/s12885-015-1714-y.
PubMed 26493267
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT01196234
- Acronym / sponsor ID
- PRIDE / AMC 2009-0677
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 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.
This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations.
Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.
Detailed description
A randomized phase II trial that compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with NSCLC without EGFR mutations. While previous studies with cytotoxic agents and gefitinib failed to show any benefit, we altered the schedule of administration in hopes to gain synergy between agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel/Carboplatin/Gefitinib | Experimental | Drug: Paclitaxel/Carboplatin/GefitinibPaclitaxel/Carboplatin/Gefitinib |
| Paclitaxel/Carboplatin | Active comparator | Drug: Paclitaxel/CarboplatinPaclitaxel/Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- More than 18 years of age
- Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
- At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
- ECOG PS 0-2
- At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
Key exclusion criteria (8 listed)
- Patients with tumor harboring EGFR mutation.
- Prior systemic therapy for NSCLC
- Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study.
- Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
- Major surgery within 3 weeks prior to study enrollment.
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 |
|---|---|---|
| Paclitaxel/Carboplatin/Gefitinibpaclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15 | Drug | Paclitaxel/Carboplatin/Gefitinib |
| Paclitaxel/Carboplatinpaclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1) | Drug | Paclitaxel/Carboplatin |
Primary outcome
Response Rate
Time frame: average 6 months
2 secondary outcomes
progression free survival
Time frame: average 2 years
overall survival
Time frame: average 2 years
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 Jan 2013.
- Derived from this study: PubMed 26493267Choi YJ, Lee DH, Choi CM, Lee JS, Lee SJ, Ahn JH, Kim SW. Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naive non-small cell lung cancer in a clinically selected population excluding patients with non-smoking adenocarcinoma or mutated EGFR. BMC Cancer. 2015 Oct 22;15:763. doi: 10.1186/s12885-015-1714-y.
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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.
Sang-We Kim, MD principal investigator
Asan Medical Center
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 Paclitaxel/Carboplatin/Gefitinib and Paclitaxel/Carboplatin in people with Non Small Cell Lung Cancer, run by Asan Medical Center at 1 site in South Korea.
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 8 inclusion and 8 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 Jan 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 South Korea. 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?
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?
Response Rate (time frame: average 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01196234, which also lists 1 linked publication.
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 Jan 2013.