Non Small Cell Lung CarcinomaPhase 2NCT00199758
Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
A Phase 2 study testing cisplatin, Gemcitabine and Taxol in people with Non Small Cell Lung Carcinoma, run by University Hospital, Limoges at 21 sites in France.
Trial summary
The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Carcinoma
- What is being tested?
- cisplatin, Gemcitabine and Taxol
- How many people
- 227 participants
- Where
- 21 sitesFrance
- Study dates
- Sep 2003to Jun 2007
- 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
- Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
- Metastatic relapses allowed in not irradiated area.
- Age between 18 and 70 years
- Chemonaïve patients
- At least one measurable target lesion according to recist criteria in non previously irradiated area.
- Performance status < 2
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- Normal hepatic and renal function, absolute neutrophil count >1,5 giga/l, platelets >100 giga/l.
- Written informed consent.
- Life expectancy > 12 weeks.
Who cannot join
- SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
- Previous chemotherapeutic treatment.
- Symptomatic brain metastases.
- Superior vena cava syndrome.
- Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
- Peripheral neuropathy grade ≥2.
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- Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
- Hypersensitivity to paclitaxel or polysorbate 80.
- Pregnancy or breast feeding.
- Any concomitant radiotherapy, except palliative bone irradiation.
- Follow-up of the patient impossible.
- Prisoners.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Service de Pneumologie
Beauvais
Service de Pneumologie
Bordeaux
Service de Pneumologie
Charleville Mezière
Service de Pneumologie
Créteil
Service de Pneumologie
Draguignan
Service de Pneumologie
Elbeuf
Service de Pneumologie
Gap
Service de Pathologie Respiratoire
Limoges
Service de Pneumologie, Hôpital de la Croix Rousse
Lyon
Service de Pneumologie
Mantes-la-Jolie
Département des Maladies Respiratoires
Marseille
Service de Pneumologie-Allergologie
Martigues
Service de Pneumologie
Meaux
Service de Pneumologie
Mulhouse
Service de Pneumologie - Hôpital St Antoine
Paris
Service de Pneumologie, Hôpital Pontchailloux
Rennes
Hôpital Charles Nicolle, Service de Pneumologie
Rouen
Service de Pneumologie, Hôpital Bois Guillaume
Rouen
Service de Pneumologie, Hôpital Nord
Saint-Etienne
Service de Pathologie Respiratoire
Toulon Naval
Service de Pneumologie
Villefranche
About this study
Official title: A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.
The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).
Read the detailed description
Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel.
- Conditions
- Non Small Cell Lung Carcinoma
- Being tested
- cisplatin, Gemcitabine, Taxol
- Keywords
- Non small cell lung carcinoma, Cisplatin, Gemcitabine, Paclitaxel
- 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.
cisplatinDrug
GemcitabineDrug
TaxolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Complete response
2-Partial response
3-Stable disease
4-Progression
Secondary outcomes (1)
-Toxicity (NCI-CTC criteria)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionMar 2007
- Study completionJun 2007
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- 227 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Francais De Pneumo-Cancerologie
- Responsible party
- Sponsor
- Investigators
- Alain Vergnengre, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199758
- Sponsor's protocol ID
- I03022
- Status last verified
- Nov 2007
- First submitted
- 14 Sep 2005
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vergnenegre A, Tillon J, Corre R, Barlesi F, Berard H, Vernejoux JM, Le Caer H, Fournel P, Marin B, Chouaid C. A randomized phase II trial assessing in advanced non-small cell lung cancer patients with stable disease after two courses of cisplatin-gemcitabine an early modification of chemotherapy doublet with paclitaxel-gemcitabine versus continuation of cisplatin-gemcitabine chemotherapy (GFPC 03-01 Study). J Thorac Oncol. 2009 Mar;4(3):364-70. doi: 10.1097/JTO.0b013e318197f4ff.
PubMed 19155999
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00199758
- Acronym / sponsor ID
- I03022
- Conditions
- Non Small Cell Lung Carcinoma
- Keywords
- Non small cell lung carcinoma, Cisplatin, Gemcitabine, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Groupe Francais De Pneumo-Cancerologie
- Study start
- Sep 2003 (actual)
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 20 Sep 2005 (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 optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).
Detailed description
Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel.
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 (9 listed)
- Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
- Metastatic relapses allowed in not irradiated area.
- Age between 18 and 70 years
- Chemonaïve patients
- At least one measurable target lesion according to recist criteria in non previously irradiated area.
Key exclusion criteria (12 listed)
- SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
- Previous chemotherapeutic treatment.
- Symptomatic brain metastases.
- Superior vena cava syndrome.
- Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
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 |
|---|---|---|
| cisplatin | Drug | – |
| Gemcitabine | Drug | – |
| Taxol | Drug | – |
Primary outcome
1-Complete response
2-Partial response
3-Stable disease
4-Progression
1 secondary outcome
-Toxicity (NCI-CTC criteria)
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 16 Jul 2025.
- Results publication: PubMed 19155999Vergnenegre A, Tillon J, Corre R, Barlesi F, Berard H, Vernejoux JM, Le Caer H, Fournel P, Marin B, Chouaid C. A randomized phase II trial assessing in advanced non-small cell lung cancer patients with stable disease after two courses of cisplatin-gemcitabine an early modification of chemotherapy doublet with paclitaxel-gemcitabine versus continuation of cisplatin-gemcitabine chemotherapy (GFPC 03-01 Study). J Thorac Oncol. 2009 Mar;4(3):364-70. doi: 10.1097/JTO.0b013e318197f4ff.
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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.
Alain Vergnengre, MD principal investigator
University Hospital, Limoges
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, Gemcitabine and Taxol in people with Non Small Cell Lung Carcinoma, run by University Hospital, Limoges at 21 sites in France.
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 9 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: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. 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?
1-Complete response. The study lists 4 primary outcomes in all. 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 NCT00199758, 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 16 Jul 2025.