Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI

Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase I Study of the Combination of Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02066870
• Other study ID #: BD-IC-IV55
• Status: Recruiting
• Phase: Phase 1
• First received: February 17, 2014
• Last updated: March 12, 2015
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Yuankai Shi, MD
• Phone: 0086-13701251865
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The NSCLC patients who experienced good clinical responses to an EGFR-TKI will inevitably develop acquired resistance. A great deal of research are focusing on this issue. Arsenic trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and other solid tumors. Moreover, preclinical studies showed arsenic trioxide can reduce the resistance of tumor cells to chemotherapy and TKIs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed stage IIIB/IV lung cancer with EGFR mutation

• Progressed after platinum-based chemotherapy

• The last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months

• With a measurable disease with conventional CT) according to RECIST Criteria

• WHO performance status(PS)<= 2

• N>=1.5×109/L, Plt>=1.0×109/L,Hb>=9g/dL; AST&ALT should <2.5ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.

• Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

• Allergic to icotinib or arsenic trioxide.

• Patients with metastatic brain tumors with symptoms.

• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib
Icotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity.
• Arsenic trioxide
Arsenic trioxide is administered by intravenous injection with an initial dose of 4mg/m2 per day for day 1 to day 14 every 21 days. Three dose levels, 4mg/m2, 6mg/m2 and 8mg/m2 will be evaluated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT. There was no further dose escalation when this dose was achieved.

Locations

Country	Name	City	State
China	Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Serious and Non-Serious Adverse Events		Up to 8 weeks	Yes
Secondary	Progression-free survival		Up to 4 months	No
Secondary	Time to death		Up to 24 months	No