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

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.

Study Overview

• Status: Unknown
• Conditions: Non-squamous Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: apatinib docetaxel zoledronic; Drug: docetaxel zoledronic

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei
    • BaoDing, Hebei, China
      • Recruiting
      • Affiliated Hospital of Hebei University
      • Contact: Aimin Zang; Phone Number: 13930881628; Email: 15175292891@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age:18 to 75 years old (man or female)
2. Pathologically diagnosed with metastatic or recurrent non-squamous non-small cell lung cancer
3. 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)
4. Refractory or failure of prior therapy
5. Life expectancy greater than or equal to 3 months
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

7. Major organ function has to meet the following criteria:

   • For results of blood routine test (without blood transfusion within 14 days)

     1. HB≥90g/L
     2. ANC≥1.5×109/L
     3. PLT≥180×109/L

   • For results of blood biochemical test：

     1. TBIL<1.5×ULN；
     2. ALT and AST<2.5×ULN, but< 5×ULN if the transferase elevation is due to liver metastases；
     3. Serum creatinine ≤1.25×ULN , or calculated creatinine clearance>45 ml/min(per the Cockcroft-Gault formula);
8. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Allergic to apatinib and docetaxel;
2. 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;
3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
4. 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;
5. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency.
6. Patients with symptoms of central nervous system metastasis.
7. Pregnant or lactating women.
8. history of psychiatric drugs abuse and can't quit or patients with mental disorders.
9. Less than 4 weeks from the last clinical trial.
10. The researchers think inappropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: apatinib and docetaxel zoledronic; 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; 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
Active Comparator: docetaxel zoledronic; docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: docetaxel zoledronic; docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	evaluation per 2 cycles (6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）	measured pain, a fracture, the need for bone radiation or surgical therapy, spinal cord compression, or hypercalcemia	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)

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Hebei University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 30, 2016
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 14, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Apatinib
• Other Study ID Numbers: AHHU-2017AMZ01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No