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

NCT ID: NCT02066870

Last Updated: 2015-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

Brief 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Icotinib and arsenic trioxide

Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.

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.

Group Type: EXPERIMENTAL

Icotinib

Intervention Type: DRUG

Icotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity.

Arsenic trioxide

Intervention Type: DRUG

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.

Interventions

Icotinib

Icotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

BPI-9000; Commana; Arsenic trioxide for injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saijuan Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Yuankai Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Locations

Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuankai Shi, MD

Role: CONTACT

0086-13701251865

Facility Contacts

Yuankai Shi, MD

Role: primary

Other Identifiers

BD-IC-IV55

Identifier Type: -

Identifier Source: org_study_id