IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300586
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : December 30, 2011
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :

  • Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
  • Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.

Condition or disease Intervention/treatment Phase
Stage IV Non-small Cell Lung Cancer Drug: observation Drug: gemcitabine Drug: erlotinib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 842 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib
Study Start Date : June 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: A (supervision)
medical supervision, second line chemotherapy if progression
Drug: observation
observation, second line chemotherapy if progression
Active Comparator: B (gemcitabicine)
Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression
Drug: gemcitabine
1250 mg/m² D1, D8 q21 days
Experimental: C (Erlotinib)
Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression
Drug: erlotinib
150 mg daily

Primary Outcome Measures :
  1. Progression free survival since randomization [ Time Frame: time until progression ]

Secondary Outcome Measures :
  1. Overall survival, [ Time Frame: no time limit ]
  2. toxicity (NCIC-CTC 3.0), [ Time Frame: time until progression ]
  3. quality of life (as assessed by LCSS). [ Time Frame: until progression ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted.
  • Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement.
  • Measurable disease according to the RECIST criteria.
  • Prior radiotherapy authorized except for irradiation concerning measurable disease.
  • Age >18 and < 70 years.
  • PS < 2.
  • Normal hepatic function : serum bilirubin < 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) < 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be < 5 x ULN.
  • Creatinine clearance > 60 mL/min.
  • Granulocyte count > 1,5 giga/L, platelet count > 100 giga/L.
  • Life expectancy > 12 weeks.
  • Written (signed) informed consent for use of tumors samples.
  • Written (signed) informed consent to participate in the sudy.

Exclusion Criteria:

  • Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma.
  • PS > 1.
  • Prior chemotherapy other than cisplatin-gemcitabine.
  • Prior therapy with EGFR inhibitor (e.g. monoclonal antibody).
  • No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital.
  • Concomitant radiotherapy except for localized bone irradiation.
  • Symptomatic brain metastases.
  • Superior vena cava syndrome.
  • Any unstable systemic disease : significant cardiovascular disease including myocardial infarction within the previous year, active infection, significant hepatic or renal disease.
  • Pre-existing interstitial lung disease.
  • Any inflammatory changes of the surface of the eyes.
  • Psychiatric disease with inability to understand the study or to comply with follow-up procedures.
  • Grade > or = 2 peripheral neuropathy.
  • Any other malignancies within 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
  • Pregnant or lactating women ; patients with reproductive potential must use effective contraception.
  • Inability to comply with follow-up procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300586

Maurice PEROL
Lyon, France, 69317
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Maurice Pérol, MD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon Identifier: NCT00300586     History of Changes
Other Study ID Numbers: 2005.386
First Posted: March 9, 2006    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011

Keywords provided by Hospices Civils de Lyon:
Non-small cell lung cancer ;
metastatic ;
chemotherapy ;

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors