NSCLC
Conditions
Keywords
NSCLC, women, CT-2103, paclitaxel, carboplatin
Brief summary
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.
Interventions
DRUGCT-2103/carboplatin
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.
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.
Sponsors
CTI BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | up to 3 years post treatment |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety | up to 3 years post treatment |
Countries
United States
Outcome results
None listed