Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
Condition: Lung Cancer, Non-Small Cell; Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Topotecan/Docetaxel combination; Docetaxel
Intervention MeSH terms: Docetaxel; Topotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HYCAMTIN; TAXOTERE; non-small cell lung cancer; NSCLC; docetaxel; topotecan; Stage IIIB/IV; Advanced

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.
    

Eligibility 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.