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The purpose of this study is to compare Paclitaxel Poliglumex plus Carboplatin to Paclitaxel plus Carboplatin for the treatment of non-small cell lung cancer in women. Patients will be randomized to either Arm 1 - Paclitaxel poliglumex plus carboplatin, or Arm 2 - Paclitaxel plus Carboplatin. Each cycle of treatment will be given every 21 days, up to a maximum of 6 cycles. Once treatment is complete, you will be contacted every 4 weeks (indefinitely) for follow-up.

Basic Inclusion/Exclusion Criteria:
• Adult Women with estradiol > 30 pg/mL
• Diagnosis of advanced non-small cell lung cancer (NSCLC)
• No prior systemic chemotherapy for the treatment of lung cancer
• Patients with known brain metastases must have received standard antitumor treatment and neurologic function must be stable for 2 weeks prior to randomization.
• Life expectancy ? 12 weeks
• Body Mass Index (BMI) cannot be > 35.
• Recurrent disease following radiation or surgery, Stage IIIB who are not candidates for CMT, or Stage IV
• Adequate bone marrow, renal, cardiac, and hepatic function
• No known sensitivity to CT-2103, paclitaxel, or carboplatin
• No grade 2 or greater neuropathy.
• No pregnant women or nursing mothers. Must agree to use contraception.
• No weight loss > 10% in the past 6 months.
• No concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
• No clinically significant active infection for which treatment is currently being given.

Study Summary:

Detailed Study Description:

Study Design: Interventional
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Non-Small Cell Lung Cancer
Intervention Type: Chemotherapy
Intervention Name: Paclitaxel Poliglumex plus Carboplatin, OR Paclitaxel plus Carboplatin
Gender: Female
Age group: Interventional
Sponsor: Cell Therapeutics, Inc. (CTI)