Study of Chemotherapy Sequenced by or Combined With EGFR-TKIs for NSCLC Patients Failed to EGFR-TKIs Therapy

NCT01746277 | Unknown Phase 2

• 1 other identifier: PUMCH S-462
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There are two different treatment modes for NSCLC patients who failed to epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) after initially responding to EGFR-TKI. One is EGFR-TKI combined with chemotherapy and the other is chemotherapy followed by EGFR-TKI. It is unclear which one is more suitable to this group of lung cancer patients. So this phase Ⅱclinical trial is designed to compare the efficiency and safety of these two different treatment modes.

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancer; chemotherapy; epidermal growth factor receptor tyrosine kinase inhibitor; retreatment

Outcome Measures

Primary Outcomes (1)

• progression free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

  up to 52 weeks (about one year)

Secondary Outcomes (4)

• overall survival

  up to 100 weeks

• objective response rate

  up to 9 weeks

• the score of functional assessment of cancer treatment-lung(FACT-L)

  up to 100weeks

• Number of participants with adverse events

  Participants will be followed for the duration of treatment, an expected average of 52 weeks.

Study Arms (2)

combined group

OTHER

combined group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycle is 6 depending on disease evaluation and patient's physical condition combined with gefitinib 250mg once per day from the start day of chemotherapy until disease progression or intolerable side effects.

Drug: combined group

sequenced group

OTHER

sequenced group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycles is 6 depending on disease evaluation or patient's physical condition sequenced by gefitinib 250mg once per day until disease progression or intolerable side effects.

Drug: Sequenced group

Interventions

combined group DRUG

chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycle is 6 depending on disease evaluation and patient's physical condition combined with gefitinib 250mg once per day from the start day of chemotherapy until disease progression or intolerable side effects.

Also known as: Docetaxel (Taxotere), Pemetrexed (Alimta), Gefitinib (Iressa)

combined group

Sequenced group DRUG

sequenced group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycles is 6 depending on disease evaluation or patient's physical condition sequenced by gefitinib 250mg once per day until disease progression or intolerable side effects.

Also known as: Docetaxel (Taxotere), Pemetrexed (Alimta), Gefitinib (Iressa)

sequenced group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• histologically and cytologically proven non-small cell bronchogenic carcinoma (sputum cytology alone was not acceptable)
• clinical stages ⅢB or Ⅳ
• recurrent or refractory disease following previous first-line chemotherapy regimens containing platinum and second-line EGFR-TKIs therapy
• partial remission (PR) or stable disease (SD) at least for 6 months during previous EGFR-TKI treatment
• at least one bidimensionally measurable or radiographically assessable lesion
• Eastern cooperative oncology group performance status (ECOG PS) ≤ 2
• life expectancy ≥ 12 weeks
• adequate hematological, renal, and hepatic functions

You may not qualify if:

• additional malignancies
• uncontrolled systemic disease
• any evidence of clinically active interstitial lung disease
• newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery
• pregnancy or breast feeding phase

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Respiratory Medicne, Peking Union Medical Hospital

Beijing, 100730, China

RECRUITING

Related Publications (4)

• Oh IJ, Ban HJ, Kim KS, Kim YC. Retreatment of gefitinib in patients with non-small-cell lung cancer who previously controlled to gefitinib: a single-arm, open-label, phase II study. Lung Cancer. 2012 Jul;77(1):121-7. doi: 10.1016/j.lungcan.2012.01.012. Epub 2012 Feb 12.

  PMID: 22333554 RESULT

• Li J, Hao X, Wang Y, Zhang X, Shi Y. [Clinical response to gefitinib retreatment of lung adenocarcinoma patients who benefited from an initial gefitinib therapy: a retrospective analysis]. Zhongguo Fei Ai Za Zhi. 2012 Jan;15(1):44-8. doi: 10.3779/j.issn.1009-3419.2012.01.09. Chinese.

  PMID: 22237124 RESULT

• Watanabe S, Tanaka J, Ota T, Kondo R, Tanaka H, Kagamu H, Ichikawa K, Koshio J, Baba J, Miyabayashi T, Narita I, Yoshizawa H. Clinical responses to EGFR-tyrosine kinase inhibitor retreatment in non-small cell lung cancer patients who benefited from prior effective gefitinib therapy: a retrospective analysis. BMC Cancer. 2011 Jan 1;11:1. doi: 10.1186/1471-2407-11-1.

  PMID: 21194487 RESULT

• Becker A, Crombag L, Heideman DA, Thunnissen FB, van Wijk AW, Postmus PE, Smit EF. Retreatment with erlotinib: Regain of TKI sensitivity following a drug holiday for patients with NSCLC who initially responded to EGFR-TKI treatment. Eur J Cancer. 2011 Nov;47(17):2603-6. doi: 10.1016/j.ejca.2011.06.046. Epub 2011 Jul 23.

  PMID: 21784628 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Pemetrexed; Gefitinib

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Quinazolines

Study Officials

• Mengzhao Wang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengzhao Wang, MD

CONTACT

010-69155039; mengzhaowang@sina.com

Jing Zhao, MD

CONTACT

010-69158206; zhaojing0@163.com

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: December 4, 2012
• First Posted: December 10, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: June 1, 2016
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

CN (1)