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

NCT ID: NCT00199758

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2007-06-30

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.

Conditions

Non Small Cell Lung Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Taxol

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Francais De Pneumo-Cancerologie

OTHER

Sponsor Role: collaborator

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Vergnengre, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 19155999 (View on PubMed)

Other Identifiers

I03022

Identifier Type: -

Identifier Source: org_study_id