Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Lung Cancer, Non-Small Cell

Non-Small-Cell Lung Cancer

Treatments

Drug: Topotecan/Docetaxel combination

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00065182

2004-002892-17 (EudraCT Number)

104864/615

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.

Enrollment

399 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent
At least 18 years old
Confirmed advanced non-small cell lung carcinoma (NSCLC)
Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN. In addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.
Presence of either measurable or non-measurable disease by radiologic study or physical examination.
Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy.
At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
At least 7 days since prior radiotherapy.
A probable life expectance of at least 3 months.
Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.

Exclusion criteria

Concomitant malignancies or other malignancies within the last five years.
Symptoms of brain metastases requiring treatment with steroids.
Active infection.
Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk.
Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
Use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication.
Women who are pregnant or lactating.
Subjects of child-bearing potential refusing to practice adequate contraception.
Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE.
Subjects who cannot receive steroid premedication.