NCT00077883

Brief Summary

The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

3 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, 2004

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 25, 2011

Status Verified

June 1, 2005

Enrollment Period

3.1 years

First QC Date

February 12, 2004

Last Update Submit

July 21, 2011

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Primary Objectives of the Study

    1. To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) 2. To determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)

    Every 3 weeks

Interventions

TLK286, cisplatinDRUG

TLK286 administered once every 3 weeks (± 2 days) at two dose-ranging levels (750 mg/m²) and 1,000 mg/²) in combination with two dose levels of cisplatin (75 mg/m² and 100 mg/m²) of cisplatin once every 3 weeks (± 2 days).

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Histologically confirmed non-small cell lung cancer
  • Stage IV or IIIB
  • Measurable disease by RECIST
  • ECOG performance status of 0-1
  • Adequate liver and renal function
  • Adequate bone marrow reserve

You may not qualify if:

  • History of bone marrow transplantation or stem cell support
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Univ. of MD, Greenbaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

The Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Univ. of TX, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TER 286Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 12, 2004

First Posted

February 16, 2004

Study Start

February 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

July 25, 2011

Record last verified: 2005-06

Locations

US(3)