Skip to main content
OpenTrials
Completed

NCT Number: NCT00300586

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stage IV Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maurice PEROL

Lyon, 69317, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observation

Drug

observation, second line chemotherapy if progression

Gemcitabine

Drug

1250 mg/m² D1, D8 q21 days

Erlotinib

Drug

150 mg daily

Primary outcomes

  1. Progression free survival since randomization

    Time frame: time until progression

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2006
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.