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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00300586
First received: March 6, 2006
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Stage IV Non-small Cell Lung Cancer
Drug: observation
Drug: gemcitabine
Drug: erlotinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Progression free survival since randomization [ Time Frame: time until progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, [ Time Frame: no time limit ] [ Designated as safety issue: No ]
  • toxicity (NCIC-CTC 3.0), [ Time Frame: time until progression ] [ Designated as safety issue: Yes ]
  • quality of life (as assessed by LCSS). [ Time Frame: until progression ] [ Designated as safety issue: No ]

Enrollment: 842
Study Start Date: June 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300586

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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00300586     History of Changes
Other Study ID Numbers: 2005.386
Study First Received: March 6, 2006
Last Updated: December 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 22, 2014