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

Primary Purpose

Non-small Cell Lung Cancer(NSCLC)

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
erlotinib
docetaxel
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer(NSCLC) focused on measuring Non-small Cell Lung Cancer(NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology, National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

erlotinib

Chemotherapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of Adverse Event

Secondary Outcome Measures

Full Information

First Posted
September 24, 2013
Last Updated
January 14, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02036359
Brief Title
Erlotinib Monotherapy Versus Docetaxel and Cisplatin as Neoadjuvant Therapy in Patients of stageIIIA Lung ca
Acronym
Oncology
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer(NSCLC)
Keywords
Non-small Cell Lung Cancer(NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
erlotinib
Arm Type
Active Comparator
Arm Description
Patients in erlotinib arm will take erlotinib 150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Adverse Event
Time Frame
Within 28 days of last study dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chong Jen YU, M.D., Ph.D
Email
jefferycjyu@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chiung Hui Huang
Phone
886-2-23123456
Ext
67779
Email
qoojoan@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chong-Jen Yu, M.D., Ph.D.
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, National Taiwan University Hospital
City
Taipei,
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chong Jen YU, M.D., Ph.D.
Email
jefferycjyu@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

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

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