Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369629
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2006-08-24
Brief Title:
Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase III Trial of GemcitabinePemetrexed Combination in Patients With Advanced Cutaneous T-Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This was planned as a phase III study originally but due to a lack of funding the phase II portion was never conducted
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 such as gemcitabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving gemcitabine together with pemetrexed disodium may kill more cancer cells
PURPOSE This was planned as a phase III trial studying the side effects and determining the best dose of gemcitabine hydrochloride when given together with pemetrexed disodium Unfortunately due to a lack of funding the phase II portion was never conducted
PURPOSE This was planned as a phase III trial studying the side effects and determining the best dose of gemcitabine hydrochloride when given together with pemetrexed disodium Unfortunately due to a lack of funding the phase II portion was never conducted
Detailed Description:
OBJECTIVES
1 Determine the safety and tolerability of gemcitabine hydrochloride and pemetrexed disodium in patients with advanced mycosis fungoides or Sézary syndrome Phase I
2 Determine the maximum tolerated dose of gemcitabine hydrochloride when administered with pemetrexed disodium in these patients Phase I
OUTLINE This is a phase I dose-escalation study of gemcitabine hydrochloride Originally this was designed to be followed by a phase II portion to determine the efficacy in this population Unfortunately due to a lack of funding the phase II portion was never conducted
During Phase I Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV on days 1 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
1 Determine the safety and tolerability of gemcitabine hydrochloride and pemetrexed disodium in patients with advanced mycosis fungoides or Sézary syndrome Phase I
2 Determine the maximum tolerated dose of gemcitabine hydrochloride when administered with pemetrexed disodium in these patients Phase I
OUTLINE This is a phase I dose-escalation study of gemcitabine hydrochloride Originally this was designed to be followed by a phase II portion to determine the efficacy in this population Unfortunately due to a lack of funding the phase II portion was never conducted
During Phase I Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV on days 1 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| STU00006771 | OTHER | Northwestern University IRB | httpsreporternihgovquickSearchP30CA060553 |
| P30CA060553 | NIH | None | None |