Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

NCT01669707 | Unknown Phase 2 DMC

• 1 other identifier: BeijingCH001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).

Conditions

Non-small Cell Lung Cancer

Keywords

Endostar; advanced Non-small cell lung cancer; Continued Pumping into vein; Gemcitabine; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  two years

Secondary Outcomes (3)

• Overall survival (OS)

  two years

• Clinical benefit rate (CBR)

  two years

• Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability

  two years

Study Arms (2)

Endostar -Continued Pumping into+GP

EXPERIMENTAL

Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin

Drug: Endostar -Continued Pumping into+GP

Endostar -injecting into +GP

ACTIVE COMPARATOR

Endostar that is injecting into vein with Gemcitabine -Cisplatin

Drug: Endostar -injecting into +GP

Interventions

Endostar -Continued Pumping into+GP DRUG

Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2\*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles.

Endostar -Continued Pumping into+GP

Endostar -injecting into +GP DRUG

Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-4cycles

Endostar -injecting into +GP

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically diagnosed NSCLC;
• primary treatment,inoperable stage IIIB/IV NSCLC;
• Age of 18-75years; Gender Not Required;
• Adequate hematologic, renal, and hepatic function ,Specific index as follows:
• liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10\^9/l, ANC≥2.0×10\^9/l platelet count ≥100×10\^9/l, Hb≥100 g/l;
• ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
• The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
• No history of serious drug allergy;
• Informed consent should be obtained before treatment.

You may not qualify if:

• Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
• Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
• Serious complications and investigator consider it is unsuited enrolling;
• Pregnant or lactating women;
• Allergic to research drug;
• participating in other experimental trials and receive the treatment in four weeks;
• The position that is for observing curative effect have a radiotherapy.

Sponsors & Collaborators

• Beijing Chest Hospital: lead

Study Sites (1)

The Beijing Chest Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Liyan Xu, MD

CONTACT

xuliyan2009@yahoo.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Oncology Department

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 21, 2012
• Study Start: April 1, 2011
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

CN (1)