Clinical trial NCT02191059: Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Wild Type EGFR
Icotinib
Second-line Treatment
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Overall Response Rate(ORR)
timeFrame: 10-12 months
Secondary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 10-12 months
measure: Overall Survival(OS)
timeFrame: 10-12momths
measure: Health Related Quality of Life(HRQoL)
timeFrame: 10-12months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Zhehai Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: