Clinical trial NCT00199758: Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Carcinoma
Keywords: Non small cell lung carcinoma
Cisplatin
Gemcitabine
Paclitaxel
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Groupe Francais De Pneumo-Cancerologie
First posted: 2005-09-20
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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
* Normal hepatic and renal function, absolute neutrophil count \>1,5 giga/l, platelets \>100 giga/l.
* Written informed consent.
* Life expectancy \> 12 weeks.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: 1-Complete response
measure: 2-Partial response
measure: 3-Stable disease
measure: 4-Progression
Secondary outcomes:
measure: -Toxicity (NCI-CTC criteria)
Other outcomes:
Locations:
city: Beauvais
country: France
facility: Service de Pneumologie
city: Bordeaux
country: France
facility: Service de Pneumologie
city: Charleville Mezière
country: France
facility: Service de Pneumologie
city: Créteil
country: France
facility: Service de Pneumologie
city: Draguignan
country: France
facility: Service de Pneumologie
city: Elbeuf
country: France
facility: Service de Pneumologie
city: Gap
country: France
facility: Service de Pneumologie
city: Limoges
country: France
facility: Service de Pathologie Respiratoire
city: Lyon
country: France
facility: Service de Pneumologie, Hôpital de la Croix Rousse
city: Mantes La Jolie
country: France
facility: Service de Pneumologie
city: Marseille
country: France
facility: Département des Maladies Respiratoires
city: Martigues
country: France
facility: Service de Pneumologie-Allergologie
city: Meaux
country: France
facility: Service de Pneumologie
city: Mulhouse
country: France
facility: Service de Pneumologie
city: Paris
country: France
facility: Service de Pneumologie - Hôpital St Antoine
city: Rennes
country: France
facility: Service de Pneumologie, Hôpital Pontchailloux
city: Rouen
country: France
facility: Hôpital Charles Nicolle, Service de Pneumologie
city: Rouen
country: France
facility: Service de Pneumologie, Hôpital Bois Guillaume
city: saint Etienne
country: France
facility: Service de Pneumologie, Hôpital Nord
city: Toulon naval
country: France
facility: Service de Pathologie Respiratoire
city: Villefranche
country: France
facility: Service de Pneumologie
Study officials:
affiliation: University Hospital, Limoges
name: Alain Vergnengre, MD
role: PRINCIPAL_INVESTIGATOR
References: