Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00996346
Status:
TERMINATED
Last Update Posted:
2015-09-01
First Post:
2009-10-14
Brief Title:
Phase III Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
Phase III Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Original PI left institution and sponsor decided to end support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Refractory soft tissue sarcoma remains a difficult malignancy to treat The mammalian target of rapamycin mTOR is an enzyme that plays an important role in cancer cell survival mTOR inhibitors like temsirolimus have shown activity in sarcoma Irinotecan is a chemotherapy drug that has also been used to treat sarcoma However it is unknown whether combining these two drugs would result in improved efficacy with acceptable toxicity
Therefore the goal of this phase I study is to determine the maximum tolerated dose MTD and toxicity profile of combination temsirolimus and irinotecan both administered intravenously on a weekly basis to refractory soft tissue sarcoma patients
Therefore the goal of this phase I study is to determine the maximum tolerated dose MTD and toxicity profile of combination temsirolimus and irinotecan both administered intravenously on a weekly basis to refractory soft tissue sarcoma patients
Detailed Description:
Mammalian target of rapamycin mTOR inhibitors are anti-neoplastic agents with a wide potential range of clinical applications The topoisomerase I inhibitor irinotecan is a potent DNA damaging drug mTOR appears to enhance cancer cell survival following DNA damage so its reasonable to expect that mTOR inhibition combined with irinotecan may result in synergistic activity
This is a single arm non-randomized phase I trial of temsirolimus an mTOR inhibitor and irinotecan a topoisomerase I inhibitor in refractory soft tissue sarcoma patients Successive groups of three patients will be entered at escalating dose levels Irinotecan and temsirolimus will be administered weekly for three weeks followed by one week of rest One course will therefore be four weeks No intra-patient dose escalation will be allowed Each patient will be treated until disease progression or intolerable side effects develop Dose limiting toxicities will be assessed and the maximum tolerated dose will be reported
Note that this trial was originally designed as a phase III study but only the phase I portion was completed and will be reported
This is a single arm non-randomized phase I trial of temsirolimus an mTOR inhibitor and irinotecan a topoisomerase I inhibitor in refractory soft tissue sarcoma patients Successive groups of three patients will be entered at escalating dose levels Irinotecan and temsirolimus will be administered weekly for three weeks followed by one week of rest One course will therefore be four weeks No intra-patient dose escalation will be allowed Each patient will be treated until disease progression or intolerable side effects develop Dose limiting toxicities will be assessed and the maximum tolerated dose will be reported
Note that this trial was originally designed as a phase III study but only the phase I portion was completed and will be reported
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-01940 | REGISTRY | NCI CTRP | None |
| 3066K1 | OTHER | None | None |
| 3066K1-1208 | OTHER | None | None |
| 20091334 | OTHER | None | None |