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

A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199758

Enrollment

227

Registered

2005-09-20

Start date

2003-09-30

Completion date

2007-06-30

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Carcinoma

Keywords

Non small cell lung carcinoma, Cisplatin, Gemcitabine, Paclitaxel

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.

Interventions

DRUGcisplatin

DRUGGemcitabine

DRUGTaxol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
1-Complete response	—
2-Partial response	—
3-Stable disease	—
4-Progression	—

Secondary

Measure	Time frame
-Toxicity (NCI-CTC criteria)	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026