Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer
- Registration Number
- NCT02191059
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intermittent High Dose of Icotinib 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 Intermittent High Dose of Icotinib Docetaxel 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
- Primary Outcome Measures
Name Time Method Overall Response Rate(ORR) 10-12 months
- Secondary Outcome Measures
Name Time Method Progression Free Survival(PFS) 10-12 months Overall Survival(OS) 10-12momths Health Related Quality of Life(HRQoL) 10-12months
Trial Locations
- Locations (1)
Shandong Cancer Hospital and Institute
🇨🇳Jinan, Shandong, China