Clinical Trials /

Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer

NCT02985203

Description:

This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in Patients with advanced Non-Small Cell Lung Cancer. The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer
  • Official Title: A Clinical Study to Investigate the Efficacy and Safety of Combination of Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: CTONG 1512
  • NCT ID: NCT02985203

Conditions

  • Lung Neoplasm Malignant

Interventions

DrugSynonymsArms
Vinorelbine OralNavelbineVinorelbine oral

Purpose

This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in Patients with advanced Non-Small Cell Lung Cancer. The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B).

Detailed Description

      In the 1st stage (Week 1-12), all patients will receive combination chemotherapy, i.e.
      Platinum and Navelbine, for 4 cycles. The regimen is:

      Navelbine oral 60mg/m2 d1,8 the first cycle; oral 80mg/m2 day1,8 in sequential cycles q3w
      plus cisplatin: 75mg/m2 d1 q3w.

      In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with
      acceptable tolerance and have no PD will be allocated into 2 arms, to evaluate the efficacy
      and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other
      regimen (Arm B). The allocation will be done in sequence at each site, i.e., the first
      subject who complete the combination chemotherapy with acceptable tolerance and have no PD
      will be allocated to Arm A, and the second will be allocated to Arm B, and so on. Arm A will
      continue with oral Navelbine 3 times weekly as maintenance therapy, up to 12 weeks, or till
      progression, unacceptable toxicity or death occurred. As contrast, Arm B will receive other
      therapy as per the physician's choice.

      Arm A: Navelbine oral 50mg three times per week (Day 1, 3, 5 of each week ) Arm B:
      Physician's choice (other than Navelbine oral) computed tomography (CT) or magnetic resonance
      imaging (MRI) will be done at the screening visit, Week 7, Week 13 (before the initiation of
      maintenance therapy), Week 19 (after 6 weeks of maintenance therapy), and Week 25 (after 12
      weeks of maintenance therapy), to evaluate the tumor response. The Disease Control Rate
      (proportion of patients in complete response (CR), partial response (PR) or stable disease
      (SD)) after 6 weeks and 12 weeks of maintenance therapy will be evaluated separately for the
      2 arms. And Arm B is for observational study only, and will provide rationale for control
      group selecting in future study.
    

Trial Arms

NameTypeDescriptionInterventions
Vinorelbine oralExperimentalOral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.
  • Vinorelbine Oral
Physician's choiceNo InterventionObservation or maintenance therapy other than orla navelbine.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Men or women aged ≥ 18 years with life expectancy ≥ 6 months
    
              -  Histologically or cytologically confirmed advanced (Stage III B - IV) NSCLC which has
                 not received antineoplastic treatment and not suitable for radical treatment,
                 including those have been resected more than 1 year before signing informed consent
                 form (ICF) then metastasized or relapsed and currently requiring chemotherapy
    
              -  With no history of cancer other than in situ uterine cervix cancer or skin basal cell
                 carcinoma with no active disease within 5 years prior to signing the ICF
    
              -  With at least one measurable target lesion(s) according to RECIST 1.1
    
              -  Adequate hematopoietic function
    
              -  Adequate hepatic and renal function
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
    
              -  Women of child-bearing potential must have a negative pregnancy test (urine or serum)
                 within 7 days of drug administration and agree to take an adequate contraceptive
                 measure
    
              -  Men who have sexual life and have a wife of child-bearing age must agree to take an
                 adequate contraceptive measure during and for 12 weeks after the last treatment with
                 Navelbine
    
              -  Signed written informed consent
    
              -  Able to comply with the protocol
    
            Exclusion Criteria:
    
              -  Non-small Cell Lung Cancer with positive sensitizing epidermal growth factor receptor
                 (EGFR) mutation positive or anaplastic lymphoma kinase (ALK) fusion oncogene, or with
                 unknown EGFR/ALK status
    
              -  Resectable Non-Small Cell Lung Cancer or suitable for radical radiotherapy/
                 chemotherapy
    
              -  Patients with medical conditions that the only manifestation is hydrothorax, ascites,
                 bone lesions or other unmeasurable diseases
    
              -  Symptomatic CNS metastasis (CNS metastasis which has received radiotherapy or surgery
                 and symptom has been stable for more than 4 weeks could be enrolled)
    
              -  With invasive malignancies except lung cancer
    
              -  Inadequate hematopoietic function:
    
                   -  Neutrophil <1.5*109/L;
    
                   -  Hb < 100g/L;
    
                   -  platelet count (PLT) <100*109/L
    
              -  Inadequate hepatic or renal function:
    
                   -  aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline
                      phosphatase (AKP)>2.5 upper limit of normal (ULN) in patients without liver or
                      bone metastasis
    
                   -  AST and/or ALT >1.5 ULN with AKP>2.5 ULN
    
                   -  AKP>5 ULN in patients with bone metastasis
    
                   -  ALT/AST>5 ULN in patients with liver metastasis
    
                   -  Total bilirubin > 1.5 ULN
    
                   -  Serum creatinine >1.5 ULN
    
                   -  Calculated creatinine clearance below 60ml/min (Cockcroft and Gault formula)
    
                   -  Blood calcium>ULN
    
              -  Patient is pregnant or nursing
    
              -  Patients with psychiatric disorder or other disease leading to incompliance to the
                 therapy
    
              -  Known hypersensitivity to any ingredient of the regimen
    
              -  Treatment with any investigational drug within 30 days before the beginning of
                 treatment with study drug
    
              -  Malabsorption syndrome or any other disorder affecting gastrointestinal absorption
    
              -  Any other severe, acute, or chronic medical condition or laboratory abnormality that
                 may increase the risk associated with study participation or study drug administration
                 or may interfere with the interpretation of study results and, in the judgment of the
                 Investigator, would make the patient inappropriate for the study.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Disease control rate during maintenance
    Time Frame:12 weeks
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Response rate during maintenance
    Time Frame:12 weeks
    Safety Issue:
    Description:
    Measure:Duration of response
    Time Frame:8 months
    Safety Issue:
    Description:
    Measure:progression-free survival
    Time Frame:8 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Guangdong Association of Clinical Trials

    Trial Keywords

    • lung cancer
    • vinorelbine
    • metronomic chemotherapy

    Last Updated

    February 23, 2017