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

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute
• Treatments: Docetaxel

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.