NCT02175381

Brief Summary

The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2011

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

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

February 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

June 21, 2014

Last Update Submit

May 14, 2015

Conditions

NSCLC

Keywords

Metastatic NSCLCElderly1st LinePlatinum-based treatment

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Disease evaluation at Week 8

Secondary Outcomes (4)

  • Disease control rate

    Disease evaluation at Week 8

  • Progression Free Survival

    1 year

  • Overall Survival

    1 year

  • Safety Profile

    Every two weeks up to 12 weeks

Study Arms (1)

Carbo/GEM

EXPERIMENTAL
Drug: CarboplatinDrug: Gemcitabine

Interventions

CarboplatinDRUG

Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks

Carbo/GEM
GemcitabineDRUG

Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks

Carbo/GEM

Eligibility Criteria

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

You may qualify if:

  • Age ≥70 years old
  • Cytologically or histologically documented NSCLC
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
  • World Health Organisation (WHO) performance status 0-2
  • Non-frail patients according to Comprehensive Geriatric Assessment
  • Previously treated NSCLC (or patients for whom the combination is considered adequate treatment) (for phase I part)
  • No prior chemotherapy (for phase II part)
  • Life expectancy of at least 12 weeks
  • Serum bilirubin less than 1.5 times the upper normal limit
  • Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases
  • Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance \>60 ml/min
  • Neutrophil count more than 1.5x 109 /L
  • Platelet count more than 100x 109 /L
  • Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.

You may not qualify if:

  • Hemoptysis
  • Central nervous system metastases
  • Clinically significant cardiovascular disease
  • Medically uncontrolled hypertension
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
  • Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

Heraklion, Crete, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens Athens, Greece

Athens, Greece

Location

Medical Oncology Unit NIMTS (Veterans Hospital)

Athens, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CarboplatinGemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Lambros Vamvakas, MD

    University Hospital of Herklion

    PRINCIPAL INVESTIGATOR

  • Athanasios Karambeazis, MD

    Medical Oncology Unit NIMTS (Veterans Hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2014

First Posted

June 26, 2014

Study Start

February 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 15, 2015

Record last verified: 2015-05

Locations

GR(5)