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

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.

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

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer(NSCLC)
• Intervention / Treatment: Drug: erlotinib; Drug: docetaxel

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.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei,, Taiwan
    • Recruiting
    • Department of Oncology, National Taiwan University Hospital
    • Contact: Chong Jen YU, M.D., Ph.D.; Email: jefferycjyu@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Event	Within 28 days of last study dose

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chong-Jen Yu, M.D., Ph.D., Department of Oncology, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Estimate): January 15, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Non-small Cell Lung Cancer(NSCLC)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Erlotinib Hydrochloride
• Other Study ID Numbers: 201203009MIB