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

Non-small Cell Lung Cancer(NSCLC) Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02036359
• Other study ID #: 201203009MIB
• Status: Recruiting
• Phase: Phase 2
• First received: September 24, 2013
• Last updated: January 14, 2014
• Start date: May 2012

Study information

• Verified date: January 2014
• Source: National Taiwan University Hospital
• Contact: Chong Jen YU, M.D., Ph.D
• Email: jefferycjyu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer(NSCLC)

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Oncology, National Taiwan University Hospital	Taipei,

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Event		Within 28 days of last study dose	No