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

NCT02375022 | Unknown Phase 2

• 1 other identifier: ZYTOP1501
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  6 months

Secondary Outcomes (2)

• Progression free survival

  12 months

• Safety: Number of Participants with Adverse Events

  12 months

Study Arms (1)

Endostar and icotinib

EXPERIMENTAL

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.

Drug: Endostar and icotinib

Interventions

Endostar and icotinib DRUG

Endostar and icotinib are used as combination therapy.

Also known as: Recombinant Human Endostatin Injection, Icotinib Hydrochloride Tablets

Endostar and icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead
• Jiangsu Simcere Pharmaceutical Co., Ltd.: collaborator
• Beta Pharma, Inc.: collaborator

Study Sites (1)

Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

endostar protein; icotinib; Endostatins

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Thoracic Oncology

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

CN (1)