NCT00190710

Brief Summary

To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

1 active site

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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

September 12, 2005

Last Update Submit

November 10, 2007

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Secondary Outcomes (4)

  • To determine and compare the 1-year survival produced by combined Paraplatin (carboplatin) + Gemcitabine versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2

  • To determine the safety of combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2

  • To compare the response rate between treatment groups

  • To compare the changes in QOL between treatment groups

Interventions

GemcitabineDRUG
CarboplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically positive pleural or pericardial effusion or Stage IV.
  • No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC.
  • ECOG Performance Status of 2 .
  • Patients must be at least 3 weeks since major surgery. Patients must be at least 1 week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy.
  • Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan.

You may not qualify if:

  • Any prior radiation therapy to the thoracic area.
  • Active and ongoing systemic infection.
  • Prior radiation to greater than 25% of the bone marrow.
  • ECOG PS other than 2
  • Patients with a known hypersensitivity to gemcitabine and carboplatin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dallas, Texas, 75204, United States

Location

Related Publications (1)

  • Gijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2.

    PMID: 37419867DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

GemcitabineCarboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

March 1, 2004

Study Completion

August 1, 2007

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

US(1)