Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620971
• Other study ID #: CT/07.19
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2008
• Last updated: June 24, 2014
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2014
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

This trial will evaluate whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival advantage in patients with locally advanced or metastatic NSCLC.

Description:

An unanswered question in first line treatment of non small cell lung cancer (NSCLC) is whether the administration of more than 2 active drugs provides greater efficacy than a two-drug combination. Docetaxel/gemcitabine combination is a well tolerated regimen, which has comparable efficacy to docetaxel/cisplatin or vinorelbine/cisplatin. In a recent phase II study in first line treatment of advanced or metastatic NSCLC, the sequential administration of vinorelbine/cisplatin followed by docetaxel/gemcitabine produced a response rate of 45.8% and a 1-year survival rate of 51%. The addition of bevacizumab to a platinum-based regimen provided a survival benefit in patients with advanced or metastatic NSCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) or metastatic (stage IV) non-squamous NSCLC

• Performance status (WHO) 0-1

• Adequate bone marrow (ANC = 1,500/mm3, PLT = 100,000/mm3, Hgb = 11 g/dL), liver (Bilirubin = 1.5 UNL, SGOT/SGPT = 2.5 UNL, ALP = 5 UNL), and renal function (Creatinine = UNL - if borderline, creatinine clearance should be = 60 mL/min)

• No previous chemotherapy or immunotherapy for advanced/metastatic NSCLC is allowed

--Previous radiotherapy is allowed provided that the measurable lesions are outside the radiation fields

• Measurable disease, defined as at least 1 bidimensionally measurable lesion = 20 X 10 mm

• Patient able to take oral medication

• Absence of active CNS disease

• Paraffin embedded sample of primary or metastatic tumor diagnostic specimen must be available

• Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria:

• Pregnant or lactating women

• Women of child-bearing age unable or unwilling to take effective contraceptive measures

• Active CNS disease, brain metastases, or leptomeningeal involvement

• Symptomatic neuropathy > grade1 according to the NCI CTCAE (version 3.0)

• Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, LVEF < normal, uncontrolled hypertension, ventricular arrhythmia), anticoagulation treatment or thrombotic event within the previous 6 months

• Active infection, requiring IV antibiotic treatment, within the previous 2 weeks

• Long-term oxygen therapy

• Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer

• Radiotherapy within the previous 4 weeks

• Previous radiotherapy to the only measurable lesion

• Concurrent treatment with other anti-cancer drug

• Uncontrolled hypercalcemia

• Known allergy to drugs with similar chemical structure to study drugs. Concurrent corticosteroids, except for chronic therapy with methylprednisolone = 20 mgr daily (or equivalent) for more than one month

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Vinorelbine
Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
• Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
• Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
• Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
• Gemcitabine
Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
• Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
• Docetaxel
Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
• Cisplatin
Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
• Bevacizumab
Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology	Athens
Greece	401 Military Hospital, Medical Oncology Unit	Athens
Greece	Air Forces Military Hospital, Dep of Medical Oncology	Athens
Greece	IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases	Athens
Greece	Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases	Athens
Greece	"Theagenion" Anticancer Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Time to Tumor Progression		1-year	No
Secondary	Overall Survival		1 year	No
Secondary	Quality of life assessment		Assessment every two cycles	No