Know Cancer

or
forgot password

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel (Taxotere) in Platinum-Resistant Non-Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-small-cell Lung

Thank you

Trial Information

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel (Taxotere) in Platinum-Resistant Non-Small Cell Lung Cancer

Inclusion Criteria


Inclusion criteria include:

- Histologically confirmed non-small cell bronchogenic carcinoma, including squamous
cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma
with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma

- Stage IV or Stage IIIB

- Progressed during or after first-line therapies with platinum-containing regimens in
the advanced or metastatic treatment regimen

- At least 18 years of age

- Good performance status (ECOG 0 to 1)

- Adequate liver, renal, and bone marrow function

Exclusion criteria include:

- Pregnant or lactating women

- Treatment with more than one cytotoxic therapy

- Prior radiation to the whole pelvis

- Unstable medical conditions such as uncontrolled cardiac arrhythmia

- Patients with known history of severe hypersensitivity reactions to docetaxel or
other drugs formulated with polysorbate 80

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

TLK286.2012

NCT ID:

NCT00047801

Start Date:

October 2002

Completion Date:

September 2004

Related Keywords:

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

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
UCLA Medical CenterLos Angeles, California  90095-7059
M.D. Anderson Cancer CenterHouston, Texas  77030
Cancer Institute Medical GroupLos Angeles, California  90025