Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247988
Status:
TERMINATED
Last Update Posted:
2007-04-24
First Post:
2005-11-01
Brief Title:
Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Phase II Study of Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Regulatory issuestrial temporarily suspended December 28 2005 Permanently suspended January 19 2007 Institutional Reveiw Board informed April 18 2007
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Weekly carboplatin and taxotere will be tolerable and effective as second line treatment of platinum-sensitive 6 month treatment free interval relapsed ovarian cancer
Primary efficacy parameter will be response rate CR and PR according to RECIST criteria
Secondary endpoints will be duration of response progression free survival and overall survival Toxicity will also be evaluated
Primary efficacy parameter will be response rate CR and PR according to RECIST criteria
Secondary endpoints will be duration of response progression free survival and overall survival Toxicity will also be evaluated
Detailed Description:
Ovarian cancer is the sixth most common malignancy in women with estimated 2500 cases diagnosed in 2001 and 1500 deaths Despite maximal cytoreductive therapy followed normally by a taxane and carboplatin or cisplatin chemotherapy most patients will relapse and require chemotherapy in a palliative setting The goal of this second line therapy is to prolong survival and to improve quality of life This disease has been characterized as chronic as many patients may eventually go on to respond to additional lines of therapy
Response to second line therapy has been correlated to length of time since the end of the first line treatment treatment free interval TFI Patients relapsing or progressing while on therapy are defined as platinum-refractory In North America the norm is to label patients with a TFI of 6 months or less as platinum-resistant A TFI of greater than 6 months would make a patient platinum-sensitive
These platinum-sensitive patients are generally treated with single agent carboplatin or carboplatin and taxol by 3-weekly administration The ICON-4 trial published in June 2003 compared single agent platinum to combination of platinum-taxol Patients could have received one or both of these agents in the adjuvant setting At a median follow-up of 42 months the absolute difference in 2-year survival was 7 P00004 in favor of the combination arm Thus combination platinum-taxol is the present standard of care in platinum-sensitive relapsed ovarian cancer Use of taxol is limited by persistent neuropathy in 20
Presently there is growing evidence in support of giving chemotherapy at shorter intervals at low-doses Hypothetically this allows less advancement of cancer cells through the cell cycle Moreover weekly taxanes are associated with an anti-angiogenic effect- more so with taxotere than taxol in cell-lines
Several randomized trials in breast cancer have shown the improved efficacy of weekly taxol over 3-weekly taxol The neoadjuvant study showed an increase in pCR complete response on pathologic evaluation of 10with weekly taxol The adjuvant study with 2-weekly chemotherapy showed a 7 improvement in time-to-progression over 3-weekly chemotherapy
In ovarian cancer- a Phase II study of weekly carboplatin AUC-2 with taxol 80mgm2week given on day 1815 of 28 day cycles has shown a response rate of 100 80 CR 20 PR in 21 platinum-sensitive patients- with either measurable or evaluable disease Median duration of response was 117 months 95 CI- 80-185 months 46 reported Grade I neuropathy 1 patient had febrile neutropenia and 32 had Grade 3 neutropenia
Weekly administration of taxotere with carboplatin has been studied in a Phase I study Maximum tolerated dose was Taxotere 35mgm2 with carboplatin AUC-2 At this dose no Grade 3 or 4 cytopenias were seen Nor were there significant neuropathies
Our study plans to evaluate Taxotere 35mgm2 with Carboplatin at AUC-2 given weekly 3 weekly treatments will constitute one cycle We expect to see equivalent response rates and equivalent or higher duration of responses with better toxicity profile
Response to second line therapy has been correlated to length of time since the end of the first line treatment treatment free interval TFI Patients relapsing or progressing while on therapy are defined as platinum-refractory In North America the norm is to label patients with a TFI of 6 months or less as platinum-resistant A TFI of greater than 6 months would make a patient platinum-sensitive
These platinum-sensitive patients are generally treated with single agent carboplatin or carboplatin and taxol by 3-weekly administration The ICON-4 trial published in June 2003 compared single agent platinum to combination of platinum-taxol Patients could have received one or both of these agents in the adjuvant setting At a median follow-up of 42 months the absolute difference in 2-year survival was 7 P00004 in favor of the combination arm Thus combination platinum-taxol is the present standard of care in platinum-sensitive relapsed ovarian cancer Use of taxol is limited by persistent neuropathy in 20
Presently there is growing evidence in support of giving chemotherapy at shorter intervals at low-doses Hypothetically this allows less advancement of cancer cells through the cell cycle Moreover weekly taxanes are associated with an anti-angiogenic effect- more so with taxotere than taxol in cell-lines
Several randomized trials in breast cancer have shown the improved efficacy of weekly taxol over 3-weekly taxol The neoadjuvant study showed an increase in pCR complete response on pathologic evaluation of 10with weekly taxol The adjuvant study with 2-weekly chemotherapy showed a 7 improvement in time-to-progression over 3-weekly chemotherapy
In ovarian cancer- a Phase II study of weekly carboplatin AUC-2 with taxol 80mgm2week given on day 1815 of 28 day cycles has shown a response rate of 100 80 CR 20 PR in 21 platinum-sensitive patients- with either measurable or evaluable disease Median duration of response was 117 months 95 CI- 80-185 months 46 reported Grade I neuropathy 1 patient had febrile neutropenia and 32 had Grade 3 neutropenia
Weekly administration of taxotere with carboplatin has been studied in a Phase I study Maximum tolerated dose was Taxotere 35mgm2 with carboplatin AUC-2 At this dose no Grade 3 or 4 cytopenias were seen Nor were there significant neuropathies
Our study plans to evaluate Taxotere 35mgm2 with Carboplatin at AUC-2 given weekly 3 weekly treatments will constitute one cycle We expect to see equivalent response rates and equivalent or higher duration of responses with better toxicity profile
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