| General information |
| Database: | DB00799 |
| Objective: | The insulinlike growth factor receptor is a potential target in smallcell lung cancer. they conducted a phase I study of cisplatin, etoposide plus dalotuzumab |
| Authors: | Ellis PM, et al |
| Title: | NCIC CTG IND.190phase I trial of dalotuzumab (MK0646) in combination with cisplatin and etoposide in extensivestage smallcell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2014 |
| PMID: | 24518092 |
| Trial Design |
| Clinical Trial Id: | NCT00869752 |
| Agent: | dalotuzumab
|
| Target: | The insulinlike growth factor receptor
|
| Cancer Type: | smallcell lung cancer |
| Cancer Subtype: | extensive stage small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | dalotuzumab (MK0646) + cisplatin + etoposide |
| Study Type: | NCIC CTG IND.I90phase I trial |
| Key Patients Feature: | patients with chemotherapynaive extensivestage smallcell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Two dose levels of dalotuzumab (DL1 5 mg/kg, DL2 10mg/kg IV weekly) were evaluated in combination with cisplatin (25 mg/m2) and etoposide (100 mg/m2) IV D13, every 21 days |
| Primary End Point: | determination of the recommendedphase 2 dose. |
| Secondary End Point: | response rate and toxicity. |
| Patients Number: | 12 |
| Trial Results |
| DLT_MTD: | Doselimiting toxicities (DLT) were defined as any of the following occurring during cycle 1 of therapy: unexpected febrile neutropenia or grade 4 neutropenia lasting more than 7 days; grade 4 thrombocytopenia; grade 3 or 4 nonhematological toxicities not usually observed with cisplatin and etoposide therapy (excluding alopecia, fatigue, grade 3 nausea, vomiting, diarrhea, or hyperglycemia); inability to administer cycle 2 within 14 days of planned treatment. |
| Objective Response Rate: | 67% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Dalotuzumab can be combined at full dose with standard doses of cisplatin and etoposide. The observed toxicities are consistent with that expected from cisplatin and etoposide except for hyperglycemia, which seems to be dose dependent. |