Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078845
Status:
COMPLETED
Last Update Posted:
2012-10-17
First Post:
2004-03-08
Brief Title:
Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2012-10
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 Amifostine may be effective in reducing pain numbness tingling and other symptoms of peripheral neuropathy
PURPOSE This phase II trial is studying how well amifostine works in reducing pain numbness tingling and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors
PURPOSE This phase II trial is studying how well amifostine works in reducing pain numbness tingling and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the percentage of patients with solid tumors who have persistent paclitaxel-induced peripheral neuropathy who benefit defined as a decrease of at least 20 on their FUNCTIONAL ASSESSMENT OF CANCER THERAPY GYNECOLOGIC ONCOLOGY GROUP NEUROTOXICITY FACTGOG-Ntx FACT-GOG-NTX score from treatment with subcutaneous amifostine
Determine whether there is sufficient evidence of reversal activity of this drug in these patients to justify a phase III study
Secondary
Compare the acute toxic effects of this drug administered subcutaneously in these patients vs IV administrations of this drug historically andor during the GOG-0192 study
Determine the capability of the Weinstein Enhanced Sensory Test to provide objective quantitative evidence for improvement in patients who have subjective improvement as self-reported on the FACT-GOG-NTX scale
Determine whether any benefit in patients treated with this drug is transient or lasts at least 8 weeks
OUTLINE This is an open-label multicenter study
Patients receive amifostine subcutaneously three times weekly for 4 weeks in the absence of symptom progression or unacceptable toxicity Patients achieving a complete or partial response receive an additional 4 weeks of therapy
Neuropathy symptoms are assessed using the FACT-GOG-NTX questionnaire administered at baseline weekly during therapy and at 12 weeks and the Weinstein Enhanced Sensory Test administered at baseline and at 4 8 and 12 weeks
Patients are followed at 12 weeks
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 10-20 months
Primary
Determine the percentage of patients with solid tumors who have persistent paclitaxel-induced peripheral neuropathy who benefit defined as a decrease of at least 20 on their FUNCTIONAL ASSESSMENT OF CANCER THERAPY GYNECOLOGIC ONCOLOGY GROUP NEUROTOXICITY FACTGOG-Ntx FACT-GOG-NTX score from treatment with subcutaneous amifostine
Determine whether there is sufficient evidence of reversal activity of this drug in these patients to justify a phase III study
Secondary
Compare the acute toxic effects of this drug administered subcutaneously in these patients vs IV administrations of this drug historically andor during the GOG-0192 study
Determine the capability of the Weinstein Enhanced Sensory Test to provide objective quantitative evidence for improvement in patients who have subjective improvement as self-reported on the FACT-GOG-NTX scale
Determine whether any benefit in patients treated with this drug is transient or lasts at least 8 weeks
OUTLINE This is an open-label multicenter study
Patients receive amifostine subcutaneously three times weekly for 4 weeks in the absence of symptom progression or unacceptable toxicity Patients achieving a complete or partial response receive an additional 4 weeks of therapy
Neuropathy symptoms are assessed using the FACT-GOG-NTX questionnaire administered at baseline weekly during therapy and at 12 weeks and the Weinstein Enhanced Sensory Test administered at baseline and at 4 8 and 12 weeks
Patients are followed at 12 weeks
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 10-20 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 |
|---|---|---|---|
| MDA-CCC-0223 | None | None | None |
| MDA-CCC-0203 | None | None | None |
| MDA-2003-0789 | None | None | None |