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

Primary Purpose

Lung Neoplasm Malignant

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Vinorelbine Oral
Sponsored by
Guangdong Association of Clinical Trials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasm Malignant focused on measuring lung cancer, vinorelbine, metronomic chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vinorelbine oral

Physician's choice

Arm Description

Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.

Observation or maintenance therapy other than orla navelbine.

Outcomes

Primary Outcome Measures

Disease control rate during maintenance

Secondary Outcome Measures

Response rate during maintenance
Duration of response
progression-free survival

Full Information

First Posted
November 29, 2016
Last Updated
March 10, 2020
Sponsor
Guangdong Association of Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT02985203
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
No participants were enrolled as schedule.
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Association of Clinical Trials

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm Malignant
Keywords
lung cancer, vinorelbine, metronomic chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vinorelbine oral
Arm Type
Experimental
Arm Description
Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.
Arm Title
Physician's choice
Arm Type
No Intervention
Arm Description
Observation or maintenance therapy other than orla navelbine.
Intervention Type
Drug
Intervention Name(s)
Vinorelbine Oral
Other Intervention Name(s)
Navelbine
Intervention Description
Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine
Primary Outcome Measure Information:
Title
Disease control rate during maintenance
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Response rate during maintenance
Time Frame
12 weeks
Title
Duration of response
Time Frame
8 months
Title
progression-free survival
Time Frame
8 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, PhD,MD
Organizational Affiliation
Guangdong General Hospital&Guangdong Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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