Overview

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

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Limoges
Collaborator:
Groupe Français de Pneumologie Cancérologie (GFPC)
Treatments:
Cisplatin
Gemcitabine
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.