Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer

Non Small Cell Lung Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199758
• Other study ID #: I03022
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2005
• Last updated: November 9, 2007
• Start date: September 2003
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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 doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Intervention

Drug:
• cisplatin

• Gemcitabine

• Taxol

Locations

Country	Name	City	State
France	Service de Pneumologie	Beauvais
France	Service de Pneumologie	Bordeaux
France	Service de Pneumologie	Charleville Mezière
France	Service de Pneumologie	Créteil
France	Service de Pneumologie	Draguignan
France	Service de Pneumologie	Elbeuf
France	Service de Pneumologie	Gap
France	Service de Pathologie Respiratoire	Limoges
France	Service de Pneumologie, Hôpital de la Croix Rousse	Lyon
France	Service de Pneumologie	Mantes La Jolie
France	Département des Maladies Respiratoires	Marseille
France	Service de Pneumologie-Allergologie	Martigues
France	Service de Pneumologie	Meaux
France	Service de Pneumologie	Mulhouse
France	Service de Pneumologie - Hôpital St Antoine	Paris
France	Service de Pneumologie, Hôpital Pontchailloux	Rennes
France	Hôpital Charles Nicolle, Service de Pneumologie	Rouen
France	Service de Pneumologie, Hôpital Bois Guillaume	Rouen
France	Service de Pneumologie, Hôpital Nord	saint Etienne
France	Service de Pathologie Respiratoire	Toulon naval
France	Service de Pneumologie	Villefranche

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Groupe Français de Pneumologie Cancérologie (GFPC)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-Complete response
Primary	2-Partial response
Primary	3-Stable disease
Primary	4-Progression
Secondary	-Toxicity (NCI-CTC criteria)