IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00300586

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 1250 mg/m² D1, D8 q21 days Drug: erlotinib 150 mg daily	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Progression free survival since randomization

Secondary Outcome Measures:

Overall survival,
toxicity (NCIC-CTC 3.0),
quality of life (as assessed by LCSS).

Estimated Enrollment:	435
Study Start Date:	June 2006

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 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

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

Contacts

Contact: Maurice Pérol, MD

33 4 72 07 17 28

maurice.perol@chu-lyon.fr

Locations

France
Maurice PEROL	Recruiting
Lyon, France, 69317
Contact: Maurice PEROL, MD 33 4 72 07 17 28 maurice.perol@chu-lyon.fr
Principal Investigator: Maurice Pérol, MD

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Maurice Pérol, MD

Hospices Civils de Lyon

More Information

Study ID Numbers:	2005.386
Study First Received:	March 6, 2006
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00300586
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Non-small cell lung cancer ;
metastatic ;
chemotherapy ;
erlotinib

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009