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

Sponsor

Hellenic Oncology Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT00441740

Collaborator

University Hospital of Crete (Other)

419

Enrollment

Locations

Arms

Duration (Months)

46.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Vinorelbine Drug: Gemcitabine Drug: Docetaxel Drug: Gemcitabine	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

419 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 VG	Drug: Vinorelbine Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles Other Names: Navelbine Drug: Gemcitabine Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles Other Names: Gemzar
Experimental: 2 DG	Drug: Docetaxel Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles Other Names: Taxotere Drug: Gemcitabine Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles Other Names: Gemzar

Arm

Intervention/Treatment

Experimental: 1

Drug: Vinorelbine

Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles

Other Names:

Navelbine

Drug: Gemcitabine

Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Other Names:

Gemzar

Experimental: 2

Drug: Docetaxel

Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles

Other Names:

Taxotere

Drug: Gemcitabine

Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles

Other Names:

Gemzar

Outcome Measures

Primary Outcome Measures

Overall survival [1 year]

Secondary Outcome Measures

Response rate [Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)]
Time to tumor progression [1 year]
Toxicity [Toxicity assessment on each chemotherapy cycle]
Quality of life [Assessment every two cycles]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis	Greece
2	" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases	Athens	Greece
3	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens	Greece
4	"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology	Athens	Greece
5	401 Military Hospital, Medical Oncology Unit	Athens	Greece
6	Air Forces Military Hospital, Dep of Medical Oncology	Athens	Greece
7	IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens	Greece
8	Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases	Athens	Greece
9	"Theagenion" Anticancer Hospital of Thessaloniki	Thessaloniki	Greece