Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003198
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
1999-11-01
Brief Title:
Ifosfamide and Topotecan in Treating Patients With Refractory Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Dose-Escalation Study of Topotecan and Ifosfamide in Patients With Refractory Non-Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of chemotherapy with ifosfamide and topotecan in treating patients with refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of chemotherapy with ifosfamide and topotecan in treating patients with refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated doses and sequence of topotecan and ifosfamide that can be administered daily for 3 days on an every 4 week schedule in patients with refractory solid tumors II Evaluate toxicity of topotecan and ifosfamide when administered on this schedule in this patient population III Evaluate the pharmacokinetics related to sequencing of topotecan and ifosfamide and the more efficacious less toxic schedule of treatment IV Assess the evidence of antineoplastic activity for this combination of agents
OUTLINE This is an open label dose escalation study Cohorts of 3-6 patients receive ifosfamide at an initial fixed dose plus escalating doses of topotecan by 30 minute infusion daily for 3 successive days Cycle repeats every 28 days After topotecan dosage is escalated for a total of 3 dose levels then ifosfamide dose is escalated by one dose level The first patient enrolled is treated with ifosfamide followed by topotecan for cycle 1 and for cycle 2 the order of drugs is reversed The second patient is treated with the same drugs but with topotecan administered before ifosfamide in the first cycle and then reversed in the second cycle From the third cycle onward ifosfamide is followed by topotecan but the first two cycles continue to alternate with each subsequent patient entered Filgrastim granulocyte colony-stimulating factor G-CSF is given for all cycles on days 5-12 or until the absolute granulocyte count has reached its nadir and recovered If there is no dose limiting toxicity DLT in a cohort new patients are entered at the next highest dose level If 1 of 3 patients at any level experiences DLT an additional 3 patients are treated at that level before proceeding to a higher level If 2 or more patients experience DLT at any dose level the level immediately preceding that level is defined as the maximum tolerated dose MTD Three more patients are treated at the MTD to ensure that no DLT is experienced at that level After MTD is identified 10 additional patients are accrued at that level Patients with minor response stable disease or symptomatic or marker improvement may continue on treatment for up to 6 cycles After 6 cycles continuation on treatment is at the investigators discretion
PROJECTED ACCRUAL There will be a maximum of 24 patients accrued into this study over 8 months
OUTLINE This is an open label dose escalation study Cohorts of 3-6 patients receive ifosfamide at an initial fixed dose plus escalating doses of topotecan by 30 minute infusion daily for 3 successive days Cycle repeats every 28 days After topotecan dosage is escalated for a total of 3 dose levels then ifosfamide dose is escalated by one dose level The first patient enrolled is treated with ifosfamide followed by topotecan for cycle 1 and for cycle 2 the order of drugs is reversed The second patient is treated with the same drugs but with topotecan administered before ifosfamide in the first cycle and then reversed in the second cycle From the third cycle onward ifosfamide is followed by topotecan but the first two cycles continue to alternate with each subsequent patient entered Filgrastim granulocyte colony-stimulating factor G-CSF is given for all cycles on days 5-12 or until the absolute granulocyte count has reached its nadir and recovered If there is no dose limiting toxicity DLT in a cohort new patients are entered at the next highest dose level If 1 of 3 patients at any level experiences DLT an additional 3 patients are treated at that level before proceeding to a higher level If 2 or more patients experience DLT at any dose level the level immediately preceding that level is defined as the maximum tolerated dose MTD Three more patients are treated at the MTD to ensure that no DLT is experienced at that level After MTD is identified 10 additional patients are accrued at that level Patients with minor response stable disease or symptomatic or marker improvement may continue on treatment for up to 6 cycles After 6 cycles continuation on treatment is at the investigators discretion
PROJECTED ACCRUAL There will be a maximum of 24 patients accrued into this study over 8 months
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-G98-1376 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066034 | REGISTRY | None | None |