Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00280787 | Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim | PHASE2 | COMPLETED | 24 | — | — | Nov 1, 2003 | Oct 1, 2010 | Feb 5, 2013 | 1 | United States |
Toxicity of the combination of induction carboplatin/paclitaxel/irinotecan, followed by concurrent carboplatin/paclitaxel/ZD1839 and high-dose TCRT, will be assessed by CTCAE criteria
To estimate the efficacy of 2 cycles (42 days) of induction paclitaxel/carboplatin/irinotecan, followed by concurrent carboplatin/paclitaxel/ZD1839 using RECIST criteria to evualate tumor response.
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | 175 mg/m2 administered on Day 1, of a 21 day cycle. Subjects will receive 2 cycles |
| Carboplatin | DRUG | Area Under the Curve(AUC)=5 administered on Day 1 of a 21 day cycle. Subjects will receive 2 cycles. |
| CPT-11 | DRUG | 100 mg/m2 administered on Day 1 of each 21 day cycle. Subjects will receive 2 cycles. |
| Pegfilgrastim | DRUG | 6 mg administered on Day 2 each each 21 day cylce. Subjects will receive 2 cycles of treatment. |
| Conformal radiotherapy | RADIATION | Radiation therapy will be administered with standard daily fractionation of 2.0 Gy per fraction, 5 days per week.The total dose of radiotherapy will be 74 Gy |
Inclusion Criteria: 1. Subjects 18 years of age or older. 2. Subjects with histologically or cytologically confirmed NSCLC that is considered generally unresectable or inoperable. No prior chemotherapy for NSCLC or thoracic radiotherapy is allowed. 3. Subjects with Stage IIIA or IIIB disease (clini...