Clinical trial NCT03127319: A Study of Apatinib Plus Docetaxel for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With Bone Metastases
Official title: A Study of Apatinib Plus Docetaxel for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With Bone Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-squamous Non-small Cell Lung Cancer
Lead sponsor: Affiliated Hospital of Hebei University
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival
timeFrame: evaluation per 2 cycles (6 weeks)
Secondary outcomes:
measure: Overall survival
timeFrame: evaluation per 2 cycles (6 weeks)
measure: DCR (Disease control rate)
timeFrame: evaluation per 2 cycles (6 weeks)
measure: ORR (Objective response rate)
timeFrame: evaluation per 2 cycles (6 weeks)
measure: SREs（Skeletal-related events）
timeFrame: evaluation per 2 cycles (6 weeks)
measure: Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
timeFrame: evaluation per 2 cycles (6 weeks)
Other outcomes:
Locations:
city: BaoDing
country: China
facility: Affiliated Hospital of Hebei university
state: Hebei
Study officials:
References: