TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077883
• Other study ID #: TLK286.2021
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 12, 2004
• Last updated: July 21, 2011
• Start date: February 2004
• Est. completion date: March 2007

Study information

• Verified date: June 2005
• Source: Telik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• History of bone marrow transplantation or stem cell support

• Pregnant or lactating women

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• TLK286, cisplatin
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).

Locations

Country	Name	City	State
United States	Univ. of MD, Greenbaum Cancer Center	Baltimore	Maryland
United States	Univ. of TX, MD Anderson Cancer Center	Houston	Texas
United States	The Sarah Cannon Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Telik

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objectives of the Study	To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC); 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	Yes