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

• Status: Completed
• Trial end date: 2007-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Docetaxel; Topotecan

Criteria

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.