Entry Detail
| General information | |
| Database: | DB00845 |
| Objective: | The prognosis for patients with extensivestage smallcell lung cancer remains poor. This trial was designed to evaluate irinotecan/cisplatin plus maintenance imatinib in patients with cKitpositive disease (the transmembrane receptor cKit is the product of the cKIT protooncogene). |
| Authors: | Schneider BJ, et al |
| Title: | Phase II trial of imatinib maintenance therapy after irinotecan and cisplatin in patients with cKitpositive, extensivestage smallcell lung cancer. |
| Journal: | Clin Lung Cancer. |
| Year: | 2010 |
| PMID: | 20630823 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | imatinib mesylate |
| Target: | Abl Plateletderived growth factor receptor Mast/stem cell growth factor receptor |
| Cancer Type: | smallcell lung cancer |
| Cancer Subtype: | cKitpositive, extensivestage smallcell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II trial |
| Key Patients Feature: | patients with cKitpositive, extensivestage smallcell lung cancer |
| Biomarker: | Immunohistochemistry for cKit was performed before enrollment. |
| Biomark Analysis: | Despite the selection of tumors expressing cKit, imatinib did not appear to delay disease progression after response to chemotherapy. however, this trial was underpowered because of its early termination. |
| Control Group Info: | single arm |
| Treatment Info: | Treatment consisted of irinotecan 65 mg/m2 on days 1 and 8 plus cisplatin 60 mg/m2 on day 1 and every 21 days for 4 cycles. Imatinib was administered at 400 mg twice a day until progression or unacceptable toxicity occurred. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 14 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 68% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.3 months (95% CI, 2.94.8 months). |
| Median OS A vs. C: | 7.8 months (95% CI, 5.710.0 months). |
| Adverse Event(agent arm): | The most common grade 1/2 nonhematologic toxicities from cisplatin and irinotecan were diarrhea (29%), nausea (14%), and fatigue (14%). Grade 1/2 hematologic toxicities included neutropenia (29%), anemia (43%), and thrombocytopenia (14%) |
| Conclusions: | Despite the selection of tumors expressing cKit, imatinib did not appear to delay disease progression after response to chemotherapy. Hotheyver, this trial was underpowered because of its early termination. Although disease stability with imatinib was evident in 3 patients and the therapy was well tolerated, this approach does not appear to warrant further clinical study. |