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

Sponsor

Guangdong Association of Clinical Trials (Other)

Overall Status

Terminated

CT.gov ID

NCT02985203

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasm Malignant	Drug: Vinorelbine Oral	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vinorelbine oral Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.	Drug: Vinorelbine Oral Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine Other Names: Navelbine
No Intervention: Physician's choice Observation or maintenance therapy other than orla navelbine.

Arm

Intervention/Treatment

Experimental: Vinorelbine oral

Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.

Drug: Vinorelbine Oral

Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine

Other Names:

Navelbine

No Intervention: Physician's choice

Observation or maintenance therapy other than orla navelbine.

Outcome Measures

Primary Outcome Measures

Disease control rate during maintenance [12 weeks]

Secondary Outcome Measures

Response rate during maintenance [12 weeks]
Duration of response [8 months]
progression-free survival [8 months]

Other Outcome Measures

Adverse events [8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.