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.

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).

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Carcinoma
• Intervention / Treatment: Drug: Gemcitabine; Drug: cisplatin; Drug: Taxol

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 Type: Interventional
• Enrollment: 227
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
-Toxicity (NCI-CTC criteria)

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Collaborators: Groupe Français de Pneumologie Cancérologie (GFPC)
• Investigators: Principal Investigator: Alain Vergnengre, MD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): November 12, 2007
• Last Update Submitted That Met QC Criteria: November 9, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Gemcitabine; Cisplatin; Paclitaxel; Non small cell lung carcinoma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: I03022