Non-Small Cell Lung CancerPhase 2NCT00291850
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
A Phase 2 study testing Paclitaxel, Cisplatin, Pegfilgrastim in people with Non-Small Cell Lung Cancer, run by Central European Cooperative Oncology Group at 5 sites in 3 countries.
Trial summary
A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Paclitaxel, Cisplatin, Pegfilgrastim
- How many people
- 50 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jun 2005to 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologic or cytologic diagnosis of NSCLC
- Presence of clinical Stage IIA,IIB or IIA disease
- tumor amenable to curative surgical resection
- Patients with clinically measurable lesions will be enrolled in this study.
- No prior tumor therapy
- Performance status of 0-1 on ECOG Scale
- Patients compliance and geographic proximity that allow adequate follow-up.
- Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.
Who cannot join
- Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.
- Treatment within the last 30 days with any investigational drug.
- Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- pregnancy/breast feeding
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.
Show all 9Show fewer
- poorly controlled diabetes mellitus
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- History of significant neurological or mental disorder, including seizures or dementia.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Hungary2 sites
Somogy Country Pulmo and Cardio Hospital,
Mosdós
Markusovszky Hospital
Szombathely
Poland2 sites
M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
Warsaw, 02-781
Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc
Warsaw
About this study
Official title: Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer
A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.
Read the detailed description
This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSCLC.
Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines.
Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle.
All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Paclitaxel, Cisplatin, Pegfilgrastim
- Keywords
- NSCLC
- 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, Cisplatin, PegfilgrastimDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC
Secondary outcomes (10)
>To evaluate the safety of neo-adjuvant chemotherapy with PC
- to characterize the toxicity of PC, include febrile neutropenia.
- to evaluate peri- and post-operative mortality
> to determine the pathological complete response rate
> to determine the complete tumor resection rate
> to evaluate proportion of cycle 2 and all cycles chemotherapy given with planned dose-on-time and proportion of patients receiving planned dose-on-time in cycle 2 and over all cycles.
> To evaluate the following time-to-event efficacy variables:
- disease free survival
- overall survival
> to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJun 2005
Why it stopped: no patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central European Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maciej Krzakowski, MD, Principal investigator, M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291850
- Sponsor's protocol ID
- CECOG/NSCLC.3.2.002
- Status last verified
- Apr 2012
- First submitted
- 14 Feb 2006
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00291850
- Acronym / sponsor ID
- CECOG/NSCLC.3.2.002
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no patient recruitment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central European Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Jun 2005
- First posted
- 15 Feb 2006 (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.
A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.
Detailed description
This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSCLC.
Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines.
Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle.
All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histologic or cytologic diagnosis of NSCLC
- Presence of clinical Stage IIA,IIB or IIA disease
- tumor amenable to curative surgical resection
- Patients with clinically measurable lesions will be enrolled in this study.
- No prior tumor therapy
Key exclusion criteria (9 listed)
- Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.
- Treatment within the last 30 days with any investigational drug.
- Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- pregnancy/breast feeding
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, Cisplatin, Pegfilgrastim | Drug | – |
Primary outcome
the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC
10 secondary outcomes
>To evaluate the safety of neo-adjuvant chemotherapy with PC
- to characterize the toxicity of PC, include febrile neutropenia.
- to evaluate peri- and post-operative mortality
> to determine the pathological complete response rate
> to determine the complete tumor resection rate
> to evaluate proportion of cycle 2 and all cycles chemotherapy given with planned dose-on-time and proportion of patients receiving planned dose-on-time in cycle 2 and over all cycles.
> To evaluate the following time-to-event efficacy variables:
- disease free survival
- overall survival
> to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)
Results and safety
The study was stopped early (reason given: no patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
Related trials for Non-Small Cell 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
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
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, 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.
Maciej Krzakowski, MD principal investigator
M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Cisplatin, Pegfilgrastim in people with Non-Small Cell Lung Cancer, run by Central European Cooperative Oncology Group at 5 sites in 3 countries.
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 9 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: stopped early, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Hungary, Poland, Austria. 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 was stopped early (reason given: no patient recruitment). Results are not available in the source record.
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?
the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC. 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 1 May 2012.