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Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Endostar and icotinib

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologic documentation of non small cell lung cancer, with activating epidermal growth factor receptor (defined as deletion 19 or exon 21 L858R mutation).
Stage IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system -Measureable disease
Life expectancy of >= 12 months
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Absolute neutrophil count (ANC) >= 1, 500/mm^3, platelet count >= 100,000/mm^3, hemoglobin >= 9.0 g/dL.
Total bilirubin =< 1.5 x upper limit of normal (ULN), serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN in patients without liver or bone metastases; < 5 x ULN in patients with liver or bone metastases, cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN.
Prothrombin time (PT) =< 1.5 x ULN, partial thromboplastin time (PTT) =< ULN
Urine dipstick proteinuria < 2+. Patients discovered to have >= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours.
Negative pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only.
Provide informed written consent.
Willing to return to enrolling institution for follow-up.
Willing to provide tissue and blood samples for correlative research purposes.

Exclusion Criteria:

Evidence of bleeding diathesis or coagulopathy.
Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
Anticipation of need for major surgical procedure during the course of the study.
Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy.
Serious, non-healing wound, ulcer, or bone fracture.
History of hemoptysis.
Clinically significant infections as judged by the treating investigator.
Other active malignancy

Sites / Locations

Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endostar and icotinib

Arm Description

Combination of drug: Endostar: 15mg CIV d1-9, Q3w and icotinib: 125mg TID po. If no progressive disease observed, combination treatment will continue until unacceptable toxicity or progressive disease.

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Progression free survival

Safety: Number of Participants with Adverse Events

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

NCT ID

NCT02375022

First Posted

February 10, 2015

Last Updated

March 23, 2015

Sponsor

Zhejiang University

Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd., Beta Pharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02375022

Brief Title

Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations

Official Title

A Study to Evaluate the Efficacy of Rh-Endostatin (Endostar®) in Combination With Icotinib for Advanced Non-Small Cell Lung Cancer With EGFR Mutations

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd., Beta Pharma, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This single-arm pilot study tries to invesitgate how well giving icotinib with rh-endostatin (Endostar®) works in treating patients with advanced stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. Icotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anti-angiogeneiss drug, such as rh-endostatin, can block tumor growth by inhibiting the ability of tumors to grow new blood vessels and spread. It is not yet known whether icotinib is more effective when given with rh-endostatin in NSCLC patients with EGFR activating mutations.

Detailed Description

Open-label, single-arm, prospective pilot study. Definition of advanced non small cell lung cancer: stage IIIb or IV. EGFR mutation status: activating mutation (defined as deletion 19 or exon 21 L858R mutation). Before starting study treatment, computed tomography scans of the chest, B ultrasound of abdomen, 12-lead electrocardiogram, MRI scan of brain, and a bone scan are required. Tumor response, based on investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), will be evaluated every 6 weeks during treatment. Exploratory evaluation will be performed using dynamic contrast enhanced MRI (DCE-MRI). QoL will be assessed using the core module, which will be completed by patients at baseline and before each cycle during treatment. All patients who prematurely discontinue treatment for any reason will be followed for survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endostar and icotinib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Endostar and icotinib

Other Intervention Name(s)

Recombinant Human Endostatin Injection, Icotinib Hydrochloride Tablets

Intervention Description

Endostar and icotinib are used as combination therapy.

Primary Outcome Measure Information:

Title

Objective response rate

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

12 months

Title

Safety: Number of Participants with Adverse Events

Description

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologic documentation of non small cell lung cancer, with activating epidermal growth factor receptor (defined as deletion 19 or exon 21 L858R mutation). Stage IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system -Measureable disease Life expectancy of >= 12 months Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 Absolute neutrophil count (ANC) >= 1, 500/mm^3, platelet count >= 100,000/mm^3, hemoglobin >= 9.0 g/dL. Total bilirubin =< 1.5 x upper limit of normal (ULN), serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN in patients without liver or bone metastases; < 5 x ULN in patients with liver or bone metastases, cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN. Prothrombin time (PT) =< 1.5 x ULN, partial thromboplastin time (PTT) =< ULN Urine dipstick proteinuria < 2+. Patients discovered to have >= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate < 1 g of protein in 24 hours. Negative pregnancy test done =< 7 days prior to randomization, for women of childbearing potential only. Provide informed written consent. Willing to return to enrolling institution for follow-up. Willing to provide tissue and blood samples for correlative research purposes. Exclusion Criteria: Evidence of bleeding diathesis or coagulopathy. Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy. Anticipation of need for major surgical procedure during the course of the study. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy. Serious, non-healing wound, ulcer, or bone fracture. History of hemoptysis. Clinically significant infections as judged by the treating investigator. Other active malignancy

Facility Information:

Facility Name

Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qiong Zhao

Phone

0571-87236802

doczq.2008@gmail.com

First Name & Middle Initial & Last Name & Degree

Ling Peng

Phone

0571-87236800

Drpengling@gmail.com

12. IPD Sharing Statement

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Rh-Endostatin in Combination With Icotinib for Advanced NSCLC With EGFR Mutations

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