Advanced Non-Small Cell Lung Cancer (NSCLC) in women. MedDRA version: 5.1 Level: NOS Classification code 10029514
Conditions
Interventions
Product Name: Xyotax
Product Code: CT 2103
Pharmaceutical Form: Powder and solvent for solution for infusion
CAS Number: 263351-82-2
Current Sponsor code: CT-2103
Other descriptive name: paclitaxel p
Sponsors
Cell Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Female. 2.Histologically- or cytologically-confirmed diagnosis of NSCLC. (Note: Sputum cytology alone is not acceptable for cell type. Cytologic specimens obtained by brushings, washings, or needle aspiration of a defined lesion or from a pleural effusion are acceptable). 3.ECOG performance score (PS) of 2. 4.Patients who meet one of the following criteria: •Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or •Stage IV. 5.Age superior or equal to 18 years. 6. Adequate bone marrow function demonstrated by absolute neutrophil count (ANC) > or equal to 1,500/µL and platelet count > or equal to 100,000/µL. 7.Adequate renal function demonstrated by creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: None of the following characteristics may be present: 1. Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103). 2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. 3. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. 4. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. 5. Grade 2 or greater neuropathy. 6. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9). 7. Clinically significant active infection for which active therapy is underway. 8. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. 9. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable. 10. Pregnant women or nursing mothers. 11. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel. ;Secondary Objective: Secondary objectives are to compare the progression-free survival, response rate, disease control, clinical benefit, quality of life, and the safety and tolerability of the treatment arms.;Primary end point(s): Overall survival | — |
Countries
Hungary, United Kingdom
Outcome results
None listed