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Erlotinib Monotherapy Versus Docetaxel and Cisplatin as Neoadjuvant Therapy in Patients of stageIIIA Lung ca (Oncology)

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ClinicalTrials.gov Identifier: NCT02036359
Recruitment Status : Unknown
Verified January 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 15, 2014
Last Update Posted : January 15, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
To compare clinical response (complete response and partial response) by RECIST) rates by RECIST between erlotinib monotherapy and docetaxel plus cisplatin chemotherapy

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer(NSCLC) Drug: erlotinib Drug: docetaxel Phase 2

Detailed Description:

an open-label, multi-centre, randomized, phase II study evaluating efficacy of erlotinib monotherapy vs. docetaxel plus cisplatin chemotherapy.

Patients with histological documented stage IIIA lung adenocarcinoma. The tumor specimens were examined for EGFR gene mutation (Exon 18-21).

Those with exon 19 deletion and L858R, G719X, L861Q mutation were randomized as erlotinib monotherapy or docetaxel plus cisplatin chemotherapy.

The randomization will be stratified by center

Study treatment Patients will receive treatment for 9 weeks unless disease progression, unacceptable toxicity or death.

Erlotinib arm:

Patients in erlotinib arm will take erlotinib 150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.

Chemotherapy arm:

Patients in chemotherapy arm will then receive 3 cycles (9 weeks) of chemotherapy with docetaxel 35mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 8.

Treatment failure will include patients who fail to complete 3 cycles (9 weeks) of study treatments due to disease progression or unacceptable toxicity.

Patients with no disease progression after terminating study treatment will undergo surgical resection and be followed until disease progression is noted, or study end. Survival will be recorded and analyzed.

If progressive disease or unacceptable toxicity occurs during study treatments, patients will be treated at discretion of investigator according to local protocol.

Please note:

• If it is judged by the investigator to be in the best interest of the patient, patients discontinuing study treatment may receive second-line treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase II Study of Erlotinib Monotherapy Versus Docetaxel and Cisplatin as Neoadjuvant Therapy in Patients of Stage IIIA Lung Adenocarcinoma With Epidermal Growth Factor Receptor Gene Mutation.
Study Start Date : May 2012
Estimated Primary Completion Date : June 2015


Arm Intervention/treatment
Active Comparator: erlotinib
Patients in erlotinib arm will take erlotinib 150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.
Drug: erlotinib
150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.
Other Name: Tarceva

Active Comparator: Chemotherapy

Patients in chemotherapy arm will then receive 3 cycles (9 weeks) of chemotherapy with docetaxel 35mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 8.

Treatment failure will include patients who fail to complete 3 cycles (9 weeks) of study treatments due to disease progression or unacceptable toxicity.

Patients with no disease progression after terminating study treatment will undergo surgical resection and be followed until disease progression is noted, or study end. Survival will be recorded and analyzed.

If progressive disease or unacceptable toxicity occurs during study treatments, patients will be treated at discretion of investigator according to local protocol.

Drug: docetaxel
receive 3 cycles (9 weeks) of chemotherapy with docetaxel 35mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 8.
Other Name: Taxotere




Primary Outcome Measures :
  1. Number of Adverse Event [ Time Frame: Within 28 days of last study dose ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Age ≥ 18 years, male or female

    • Able to comply with the protocol
    • Histologically documented stage IIIA lung adenocarcinoma
    • ECOG performance status 0-2
    • If the patient has the use coumarin (coumarin) (also to be called coumadin or warfarin), the patient applies drugs previous 7 days at the experiment to stop the medicine, and changes to other for to use the medicine.
    • Life expectancy > 12 weeks
    • Tumor specimen with EGFR gene mutation of exon 19 deletion and L858R, G719X, L861Q mutation
    • Adequate hematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL
    • Data of INR and PTT should be available in patients taking anticoagulants concomitantly, with INR ≤ 1.5 and PTT ≤ 1.5 times the upper limit of normal (x ULN ) within 7 days prior to starting study treatment
    • Adequate liver function: serum bilirubin ≤ 1.5 x ULN; transaminases ≤ 2.5 x ULN
    • Adequate renal function: 24-hour urine creatinine clearance or creatinine clearance measured and calculated according to the formula of Cockroft and Gault ≥ 60ml/min
    • Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women
    • Written informed consent.
    • Patients are willing to complete FACT-L, ED-5Q, or pharmacoeconomic questionnaires

Exclusion Criteria:

  • • Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor)

    • Mixed adenocarcinoma and other histological type of lung cancer
    • Unable to take oral medicine
    • Pregnant or lactating women
    • Fertile men or women of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
    • Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent
    • Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment
    • Known hypersensitivity to any of the study drugs
    • Concurrent cancer treatment

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 ClinicalTrials.gov identifier (NCT number): NCT02036359


Contacts
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Contact: Chong Jen YU, M.D., Ph.D jefferycjyu@ntu.edu.tw
Contact: Chiung Hui Huang 886-2-23123456 ext 67779 qoojoan@yahoo.com.tw

Locations
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Taiwan
Department of Oncology, National Taiwan University Hospital Recruiting
Taipei,, Taiwan
Contact: Chong Jen YU, M.D., Ph.D.       jefferycjyu@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chong-Jen Yu, M.D., Ph.D. Department of Oncology, National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02036359    
Other Study ID Numbers: 201203009MIB
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014
Keywords provided by National Taiwan University Hospital:
Non-small Cell Lung Cancer(NSCLC)
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors