Randomized Trial of Docetaxel and Gemcitabine Versus Gemc... | NCT00442026

Studies
Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

NCT00442026

Sponsor

Hellenic Oncology Research Group

Status

Terminated

Last Update Posted

Jun 27, 2012Estimated

Enrollment

106Actual

Phase

Phase 3

Conditions

Non-small-cell Lung Cancer

Interventions

Docetaxel
Gemcitabine
Gemcitabine

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to poor accrual

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Feb 28, 2007

First Submission Date that Met QC Criteria

Feb 28, 2007

First Posted Date

Mar 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2012

Last Update Posted Date

Jun 27, 2012Estimated

Name	Class
University Hospital of Crete	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	DG	Drug: Docetaxel Drug: Gemcitabine
2	Experimental	G	Drug: Gemcitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel	Drug	Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival between the two treatment arms		Probability of 1 year survival (%)

Secondary Outcomes

Measure	Description	Time Frame
Overall response rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Time to disease progression		1 year
Quality of life assessment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lampros Vamvakas, MD	University Hospital of Crete, Dep of Medical Oncology	Principal Investigator
Athanasios Karampeazis, MD	University Hospital of Crete	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University General Hospital of Alexandroupolis, Dep of Medical Oncology		Alexandroupoli			Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27264267	Derived	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.

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D009369	Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic