Clinical trial NCT00442026: Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC
Official title: A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-small-cell Lung Cancer
Keywords: Cancer
NSCLC
Elderly
Chemotherapy
Docetaxel
Gemcitabine
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-03-01
Enrollment: 106
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC

Detailed description: Docetaxel and gemcitabine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. However, there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation

Eligibility criteria: Inclusion Criteria:

* Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
* Stage IIIB/IV
* No prior chemotherapy
* Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
* Absence or irradiated and stable central nervous system metastatic disease
* Life expectancy of more than 3 months
* Age ≥ 70 years.
* Performance status (WHO) \< 3
* Patients "non-frail" according to comprehensive geriatric assessment
* Adequate bone marrow function (Absolute neutrophil count \> 1000/mm\^3, Platelet count \> 100000/mm\^3, Hemoglobin \> 9gr/mm\^3).
* Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl).
* Adequate cardiac function (LVEF \> 50%).
* Informed consent.

Exclusion Criteria:

* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
* No presence of a reliable care giver
* Other concurrent investigational agents.

Primary outcomes:
measure: Overall survival between the two treatment arms
timeFrame: Probability of 1 year survival (%)
Secondary outcomes:
measure: Overall response rate
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
measure: Time to disease progression
timeFrame: 1 year
measure: Quality of life assessment
timeFrame: Assessment every two cycles
measure: Toxicity profile
timeFrame: Assessment every two cycles
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: 401 Military Hospital, Medical Oncology Unit
city: Athens
country: Greece
facility: Air Forces Military Hospital, Dep of Medical Oncology
city: Athens
country: Greece
facility: IASO" General Hospital of Athens, 1st Dep of Medical Oncology
city: Athens
country: Greece
facility: Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
city: Athens
country: Greece
facility: Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: Theagenion" Anticancer Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Crete, Dep of Medical Oncology
name: Lampros Vamvakas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Crete
name: Athanasios Karampeazis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karampeazis A, Vamvakas L, Kotsakis A, Christophyllakis C, Kentepozidis N, Chandrinos V, Agelidou A, Polyzos A, Tsiafaki X, Hatzidaki D, Georgoulias V. Docetaxel plus gemcitabine versus gemcitabine in elderly patients with advanced non-small cell lung cancer and use of a geriatric assessment: Lessons from a prematurely closed Hellenic Oncology Research Group randomized phase III study. J Geriatr Oncol. 2017 Jan;8(1):23-30. doi: 10.1016/j.jgo.2016.05.002. Epub 2016 Jun 2.