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

Primary Purpose

Non Small Cell Lung Carcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cisplatin
Gemcitabine
Taxol
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Carcinoma focused on measuring Non small cell lung carcinoma, Cisplatin, Gemcitabine, Paclitaxel

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Service de Pneumologie
  • Service de Pneumologie
  • Service de Pneumologie
  • Service de Pneumologie
  • Service de Pneumologie
  • Service de Pneumologie
  • Service de Pneumologie
  • Service de Pathologie Respiratoire
  • Service de Pneumologie, Hôpital de la Croix Rousse
  • Service de Pneumologie
  • Département des Maladies Respiratoires
  • Service de Pneumologie-Allergologie
  • Service de Pneumologie
  • Service de Pneumologie
  • Service de Pneumologie - Hôpital St Antoine
  • Service de Pneumologie, Hôpital Pontchailloux
  • Hôpital Charles Nicolle, Service de Pneumologie
  • Service de Pneumologie, Hôpital Bois Guillaume
  • Service de Pneumologie, Hôpital Nord
  • Service de Pathologie Respiratoire
  • Service de Pneumologie

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

-Toxicity (NCI-CTC criteria)

Full Information

First Posted
September 14, 2005
Last Updated
November 9, 2007
Sponsor
University Hospital, Limoges
Collaborators
Groupe Français de Pneumologie Cancérologie (GFPC)
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1. Study Identification

Unique Protocol Identification Number
NCT00199758
Brief Title
Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges
Collaborators
Groupe Français de Pneumologie Cancérologie (GFPC)

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Carcinoma
Keywords
Non small cell lung carcinoma, Cisplatin, Gemcitabine, Paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
227 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Taxol
Primary Outcome Measure Information:
Title
1-Complete response
Title
2-Partial response
Title
3-Stable disease
Title
4-Progression
Secondary Outcome Measure Information:
Title
-Toxicity (NCI-CTC criteria)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Vergnengre, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Pneumologie
City
Beauvais
Country
France
Facility Name
Service de Pneumologie
City
Bordeaux
Country
France
Facility Name
Service de Pneumologie
City
Charleville Mezière
Country
France
Facility Name
Service de Pneumologie
City
Créteil
Country
France
Facility Name
Service de Pneumologie
City
Draguignan
Country
France
Facility Name
Service de Pneumologie
City
Elbeuf
Country
France
Facility Name
Service de Pneumologie
City
Gap
Country
France
Facility Name
Service de Pathologie Respiratoire
City
Limoges
Country
France
Facility Name
Service de Pneumologie, Hôpital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Service de Pneumologie
City
Mantes La Jolie
Country
France
Facility Name
Département des Maladies Respiratoires
City
Marseille
Country
France
Facility Name
Service de Pneumologie-Allergologie
City
Martigues
Country
France
Facility Name
Service de Pneumologie
City
Meaux
Country
France
Facility Name
Service de Pneumologie
City
Mulhouse
Country
France
Facility Name
Service de Pneumologie - Hôpital St Antoine
City
Paris
Country
France
Facility Name
Service de Pneumologie, Hôpital Pontchailloux
City
Rennes
Country
France
Facility Name
Hôpital Charles Nicolle, Service de Pneumologie
City
Rouen
Country
France
Facility Name
Service de Pneumologie, Hôpital Bois Guillaume
City
Rouen
Country
France
Facility Name
Service de Pneumologie, Hôpital Nord
City
saint Etienne
Country
France
Facility Name
Service de Pathologie Respiratoire
City
Toulon naval
Country
France
Facility Name
Service de Pneumologie
City
Villefranche
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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