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Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer

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ClinicalTrials.gov Identifier: NCT02191059
Recruitment Status : Unknown
Verified July 2014 by Zhehai Wang, Shandong Cancer Hospital and Institute.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2014
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Zhehai Wang, Shandong Cancer Hospital and Institute

Brief Summary:
  1. There is as yet no optimal treatment regimen for patients with epidermal growth factor receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) .
  2. Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably, anti-tumor activities were observed in patients with advanced NSCLC.
  3. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in combination with Docetaxel as second-line treatment for NSCLC patients with wild type EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall survival(OS) and health related quality of life(HRQoL) will be monitored.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Icotinib Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm, Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel as Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR:
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Intermittent High Dose of Icotinib

Intermittent High Dose of Icotinib in Combination With Docetaxel:

Icotinib 625mg tablet b ymouth three times per day for day1-2, Docetaxel 75mg/m2 injection intravenous drip for day 3, 3 weeks as 1 cycle

Drug: Icotinib
Drug: Docetaxel
Other Name: Taxotere, Docecad




Primary Outcome Measures :
  1. Overall Response Rate(ORR) [ Time Frame: 10-12 months ]

Secondary Outcome Measures :
  1. Progression Free Survival(PFS) [ Time Frame: 10-12 months ]
  2. Overall Survival(OS) [ Time Frame: 10-12momths ]
  3. Health Related Quality of Life(HRQoL) [ Time Frame: 10-12months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed stage IIIB/IV NSCLC patients progressing after first-line chemotherapy;
  • Patients must have stopped prior platinum-based therapy at least four weeks prior to enroll and fully recovered from chemotherapy-induced toxicity;
  • Age: 18-70 years old;
  • Patients with wild-type EGFR;
  • With a histologically or cytologically confirmed measurable disease (longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to Response Evaluation Criteria in Solid Tumors (RECIST Criteria);
  • Patients must have Eastern Cooperative Oncology Group(ECOG)Performance Status of 0-2;
  • Must have an expected survival time of at least 12 weeks;
  • Patients should have adequate bone marrow function defined as an absolute peripheral neutrophil count (ANC) of ≥1.5 ´ 109/L, platelet count of ≥ 75´ 109/L; Hemoglobin(Hb) ≥ 9g/dL;
  • adequate hepatic function: bilirubin ≤2x the upper limit of normal, glutamic-oxaloacetic transaminase(AST )and glutamate pyruvate transaminase(ALT)≤2x the upper limit of normal (≤5x the upper limit of normal if evidence of liver metastases);
  • adequate renal function: bilirubin serum creatinine ≤1.5 x the upper limit of normal;
  • No malabsorption or other gastrointestinal disorders affecting drug absorption;
  • Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to study entry.Male patients must use at least one reliable form of contraception during treatment and within 3 months after treatment;
  • Patients have provided a signed Informed Consent Form.

Exclusion Criteria:

  • Experience of Anti-EGFR Monoclonal Antibody or small molecular compounds therapy such as gefitinib, cetuximab, erlotinib or trastuzumab;
  • Concomitant use with phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort;
  • Allergic to icotinib or any of the excipients of this product.
  • Prior chemotherapy with any paclitaxel agents;
  • Central nervous system (CNS) metastases without radiotherapy and/or surgery;
  • Evidence of clinically active Interstitial lung diseases;
  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases;
  • Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non melanoma skin cancer or cervical carcinoma in situ);
  • Psychiatric illness that would prevent the patient from giving informed consent;
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study;
  • Patient is concurrently using other approved or investigational antineoplastic agent;
  • Pregnant or lactating women;
  • Positive epidermal growth factor receptor mutation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191059


Contacts
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Contact: Zhehai Wang, MD 0086-531-67626331 wzhai8778@sina.com

Locations
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China, Shandong
Shandong Cancer Hospital and Institute Not yet recruiting
Jinan, Shandong, China, 250117
Contact: Zhehai Wang, MD    0086-531-67626331    wzhai8778@sina.com   
Principal Investigator: Zhehai Wang, MD         
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
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Principal Investigator: Zhehai Wang, MD Shandong Cancer Hospital and Institute

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Responsible Party: Zhehai Wang, Vice President, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT02191059     History of Changes
Other Study ID Numbers: Icotinib
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014
Keywords provided by Zhehai Wang, Shandong Cancer Hospital and Institute:
Non Small Cell Lung Cancer
Wild Type EGFR
Icotinib
Second-line Treatment
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action