This trial is active, not recruiting.

Condition nsclc
Treatments ct-2103/carboplatin, paclitaxel/carboplatin
Phase phase 3
Sponsor CTI BioPharma
Start date September 2007
End date January 2014
Trial size 450 participants
Trial identifier NCT00576225, PGT307


This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
CT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
(Active Comparator)
Paclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.

Primary Outcomes

time frame: up to 3 years post treatment

Secondary Outcomes

progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety
time frame: up to 3 years post treatment

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Women with baseline estradiol >25 pg/mL 2. Histologically- or cytologically-confirmed diagnosis of NSCLC. 3. ECOG performance score (PS) of 0, 1, or 2. 4. Patients must meet one of the following criteria have either (1) Recurrent disease following completion of radiation or surgery, (2) Stage IIIB disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) Stage IV disease. 5. At least 18 years of age. 6. Adequate bone marrow function 7. Adequate renal function 8. Adequate hepatic function 9. Life expectancy ≥12 weeks Exclusion Criteria: 1. Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive. 2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. 3. Weight loss >10% in previous 6 months 4. LDH > 2.5X IULN 5. Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months 6. BMI >35 7. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. 8. Local palliative radiotherapy < 7 days before randomization. 9. Radiation with curative intent < 30 days before randomization. 10. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. 11. Grade 2 or greater neuropathy. 12. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. 13. Clinically significant active infection for which active therapy is underway. 14. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. 15. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. 16. Pregnant women or nursing mothers.

Additional Information

Official title Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol > 25 pg/mL
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by CTI BioPharma.