Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441740
• Other study ID #: CT/04.04
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2007
• Last updated: October 29, 2008
• Start date: April 2004
• Est. completion date: February 2008

Study information

• Verified date: October 2008
• 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

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

Description:

Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC

• No previous therapy for advanced/metastatic NSCLC is allowed

• Age > 18 years

• Bidimensionally measurable disease

• Performance status (WHO) 0-2

• Adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils = 1.5x 109 /L, and platelets = 100x 109 /L) function

• Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields

• Life expectancy of more than 3 months

• Patient able to take oral medication

• At least 4 weeks since prior radiotherapy

• Written informed consent

Exclusion Criteria:

• Active infection

• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)

• Malnutrition (loss of = 20% of the original body weight)

• Performance status: 3-4

• Sensor or motor neuropathy > grade I

• Second primary malignancy, except for non-melanoma skin cancer

• Psychiatric illness or social situation that would preclude study compliance

• Pregnant or lactating women

• Known, symptomatic central nervous system metastases

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) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
• Gemcitabine
Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
• Docetaxel
Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
• Gemcitabine
Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases	Athens
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	"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 survival		1 year	No
Secondary	Response rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Time to tumor progression		1 year	No
Secondary	Toxicity		Toxicity assessment on each chemotherapy cycle	Yes
Secondary	Quality of life		Assessment every two cycles	No