NCT00268970

Brief Summary

The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Dec 2005

Typical duration for phase_2 nonsmall-cell-lung-cancer

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

December 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

December 22, 2005

Last Update Submit

April 27, 2012

Conditions

Non-small Cell Lung Cancer

Keywords

Advanced non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel

    3 months

Secondary Outcomes (1)

  • To examine time to tumor progression, overall survival, and safety in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel

    3 months

Interventions

Satraplatin in combination with PaclitaxelDRUG

Paclitaxel 200 mg/m2 IV over 3 hours on day 1. Satraplatin 60 mg/m2 administered by mouth once daily for 5 consecutive days (days 1-5). Satraplatin will be administered within 2 hours following paclitaxel infusion on day 1. Subsequent doses on days 2-5 will be taken at approximately 24 hour intervals.

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed advanced NSCLC
  • Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry.
  • Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
  • ECOG performance status of ≤ 2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

satraplatinPaclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

December 1, 2005

Primary Completion

April 1, 2007

Study Completion

September 1, 2009

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations

US(1)