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

This study has been completed.

First Received: September 14, 2005 Last Updated: November 9, 2007 History of Changes

Sponsors and Collaborators:	University Hospital, Limoges Groupe Français de Pneumologie Cancérologie (GFPC)
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00199758

Purpose

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	Intervention	Phase
Non Small Cell Lung Carcinoma	Drug: cisplatin Drug: Gemcitabine Drug: Taxol	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Paclitaxel Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:

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

Secondary Outcome Measures:

-Toxicity (NCI-CTC criteria)

Estimated Enrollment:	227
Study Start Date:	September 2003
Study Completion Date:	June 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199758

Locations

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

Sponsors and Collaborators

University Hospital, Limoges

Groupe Français de Pneumologie Cancérologie (GFPC)

Investigators

Principal Investigator:

Alain Vergnengre, MD

University Hospital, Limoges

More Information

No publications provided

Study ID Numbers:	I03022
Study First Received:	September 14, 2005
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00199758 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

Non small cell lung carcinoma
Cisplatin
Gemcitabine
Paclitaxel

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Immunologic Factors
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Respiratory Tract Diseases
Cisplatin

Radiation-Sensitizing Agents
Lung Neoplasms
Paclitaxel
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses

Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009