NCT00401492

Brief Summary

The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

4.5 years

First QC Date

November 17, 2006

Last Update Submit

July 12, 2012

Conditions

Non Small Cell Lung Cancer

Keywords

elderlychemotherapyquality of lifeADLtoxicity

Outcome Measures

Primary Outcomes (2)

  • Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion

  • Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine

Secondary Outcomes (4)

  • patient quality of life

  • the prognostic significance of the ADL and IADL scales for time to progression and survival

  • exploratory predictive clinical variables for chemotherapy related toxicity

  • exploratory predictive clinical variables for response to chemotherapy

Interventions

gemcitabine prolonged continuous infusionDRUG
cisplatinDRUG
vinorelbineDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histologic or cytologic diagnosis of NSCLC
  • Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
  • Age \> o = 70 years.
  • Written informed consent.

You may not qualify if:

  • Performance status (ECOG) ³2
  • Previous chemotherapy.
  • Symptomatic brain metastases requiring synchronous radiotherapy
  • Previous radiotherapy (completed less than 4 weeks before enrollment)
  • Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
  • Neutrophils \< 2.000/mm³ or platelets \< 100.000/mm³ or hemoglobin \< 10 g/dl.
  • Serum creatinine \> 1.5 times the UNL.
  • GOT and/or GPT \>1.25 times the UNL or serum total bilirubin \>1.25 times the UNL without hepatic metastases.
  • GOT and/or GPT \>2.5 times the UNL or serum total bilirubin \>1.5 times the UNL with hepatic metastases.
  • Other concomitant diseases contraindicating the study treatments.
  • Refusal of written informed consent.
  • Follow-up impossible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, Bearz A, Robbiati SF, Filipazzi V, Lorusso V, Carrozza F, Iaffaioli RV, Manzione L, Gallo C, Morabito A, Perrone F. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies. J Clin Oncol. 2007 Oct 10;25(29):4663-9. doi: 10.1200/JCO.2007.12.5708.

    PMID: 17925563RESULT

  • Gridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Signoriello G, Perrone F; MILES Investigators. The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer. 2008 Jul;61(1):67-72. doi: 10.1016/j.lungcan.2007.12.002.

    PMID: 18683299RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CisplatinVinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Cesare Gridelli, M.D.

    San Giuseppe Moscati Hospital

    PRINCIPAL INVESTIGATOR

  • Francesco Perrone, M.D.

    National Cancer Institute, Naples Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

June 1, 2002

Primary Completion

December 1, 2006

Study Completion

April 1, 2007

Last Updated

July 13, 2012

Record last verified: 2012-07