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

NCT02036359 | Unknown Phase 2

• 1 other identifier: 201203009MIB
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer(NSCLC)

Keywords

Non-small Cell Lung Cancer(NSCLC)

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Event

  Within 28 days of last study dose

Study Arms (2)

erlotinib

ACTIVE COMPARATOR

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

Drug: erlotinib

Chemotherapy

ACTIVE COMPARATOR

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

Interventions

erlotinib DRUG

150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.

Also known as: Tarceva

erlotinib

docetaxel DRUG

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.

Also known as: Taxotere

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Chong-Jen Yu, M.D., Ph.D.

  Department of Oncology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chong Jen YU, M.D., Ph.D

CONTACT

jefferycjyu@ntu.edu.tw

Chiung Hui Huang

CONTACT

886-2-23123456; qoojoan@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: January 15, 2014
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

TW (1)