A Study of Apatinib Plus Docetaxel for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With Bone Metastases

NCT03127319 | Unknown Phase 2

• 1 other identifier: AHHU-2017AMZ01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line treatment for advanced non-squamous non-small cell lung cancer with bone metastases.

Conditions

Non-squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  evaluation per 2 cycles (6 weeks)

Secondary Outcomes (5)

• Overall survival

  evaluation per 2 cycles (6 weeks)

• DCR (Disease control rate)

  evaluation per 2 cycles (6 weeks)

• ORR (Objective response rate)

  evaluation per 2 cycles (6 weeks)

• SREs（Skeletal-related events）

  evaluation per 2 cycles (6 weeks)

• Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  evaluation per 2 cycles (6 weeks)

Study Arms (2)

apatinib and docetaxel zoledronic

EXPERIMENTAL

apatinib 500mg qd po; docetaxel 60mg/m² iv q3w; zoledronic 4mg iv\>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: apatinib docetaxel zoledronic

docetaxel zoledronic

ACTIVE COMPARATOR

docetaxel 60mg/m² iv q3w;zoledronic 4mg iv\>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: docetaxel zoledronic

Interventions

apatinib docetaxel zoledronic DRUG

apatinib 500 mg qd p.o.docetaxel 60mg/m² iv q3w;zoledronic 4mg iv\>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent

apatinib and docetaxel zoledronic

docetaxel zoledronic DRUG

docetaxel 60mg/m² iv q3w;zoledronic 4mg iv\>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent

docetaxel zoledronic

Eligibility Criteria

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

You may qualify if:

• Age:18 to 75 years old (man or female)
• Pathologically diagnosed with metastatic or recurrent non-squamous non-small cell lung cancer
• Patients with at least one evaluate lesions of the lung and bone metastases.(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO)
• Refractory or failure of prior therapy
• Life expectancy greater than or equal to 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Major organ function has to meet the following criteria:
• For results of blood routine test (without blood transfusion within 14 days)
• HB≥90g/L
• ANC≥1.5×109/L
• PLT≥180×109/L
• For results of blood biochemical test：
• TBIL\<1.5×ULN；
• ALT and AST\<2.5×ULN, but\< 5×ULN if the transferase elevation is due to liver metastases；
• Serum creatinine ≤1.25×ULN , or calculated creatinine clearance\>45 ml/min(per the Cockcroft-Gault formula);

You may not qualify if:

• Allergic to apatinib and docetaxel;
• Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg), with class Ⅱ and above coronary heart disease, arrhythmia (including QTc lengthened men \> 450 ms, women \> 470 ms) and class Ⅲ-Ⅳ cardiac insufficiency;
• A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
• Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months; For defecate occult blood (+) and primary lesions without surgical removal of the stomach tumor, requirement of gastroscopy, such as ulcer type of gastric cancer, and researchers think that may be gastrointestinal hemorrhage;
• Coagulant function abnormality (INR \> 1.5 ULN, APTT \> 1.5 ULN), with bleeding tendency.
• Patients with symptoms of central nervous system metastasis.
• Pregnant or lactating women.
• history of psychiatric drugs abuse and can't quit or patients with mental disorders.
• Less than 4 weeks from the last clinical trial.
• The researchers think inappropriate.

Sponsors & Collaborators

• Affiliated Hospital of Hebei University: lead

Study Sites (1)

Affiliated Hospital of Hebei university

Baoding, Hebei, China

RECRUITING

Central Study Contacts

Aimin Zang

CONTACT

13930881628; 15175292891@163.com

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: Director of oncology

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: April 25, 2017
• Study Start: July 3, 2017
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 17, 2018

Record last verified: 2017-01

Locations

CN (1)