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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Completed

CT.gov ID

NCT00199758

Collaborator

Groupe Français de Pneumologie Cancérologie (GFPC) (Other)

227

Enrollment

Locations

Duration (Months)

10.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Carcinoma	Drug: cisplatin Drug: Gemcitabine Drug: Taxol	Phase 2

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

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2003

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1-Complete response []
2-Partial response []
3-Stable disease []
4-Progression []

Secondary Outcome Measures

-Toxicity (NCI-CTC criteria) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Service de Pneumologie	Beauvais	France
2	Service de Pneumologie	Bordeaux	France
3	Service de Pneumologie	Charleville Mezière	France
4	Service de Pneumologie	Créteil	France
5	Service de Pneumologie	Draguignan	France
6	Service de Pneumologie	Elbeuf	France
7	Service de Pneumologie	Gap	France
8	Service de Pathologie Respiratoire	Limoges	France
9	Service de Pneumologie, Hôpital de la Croix Rousse	Lyon	France
10	Service de Pneumologie	Mantes La Jolie	France
11	Département des Maladies Respiratoires	Marseille	France
12	Service de Pneumologie-Allergologie	Martigues	France
13	Service de Pneumologie	Meaux	France
14	Service de Pneumologie	Mulhouse	France
15	Service de Pneumologie - Hôpital St Antoine	Paris	France
16	Service de Pneumologie, Hôpital Pontchailloux	Rennes	France
17	Hôpital Charles Nicolle, Service de Pneumologie	Rouen	France
18	Service de Pneumologie, Hôpital Bois Guillaume	Rouen	France
19	Service de Pneumologie, Hôpital Nord	saint Etienne	France
20	Service de Pathologie Respiratoire	Toulon naval	France
21	Service de Pneumologie	Villefranche	France