Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005831
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2000-06-02
Brief Title:
Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of Trastuzumab Herceptin Paclitaxel Carboplatin and Gemcitabine in the Treatment of Advanced Urothelial Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase II trial to study the effectiveness of combining trastuzumab with combination chemotherapy in treating patients who have locally recurrent or metastatic urinary tract cancer Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To assess the toxicity of the combination of Herceptin paclitaxel carboplatin and gemcitabine in patients with metastatic or locally recurrent urothelial cancers who overexpress HER2
SECONDARY OBJECTIVES
I The complete and partial response rates II The median and overall survival III To prospectively evaluate the percentage of patients with metastaticrecurrent bladder cancer who overexpress HER2 histologically by immunohistochemistry and FISH and serologically
IV To generate preliminary data on response to other therapy and survival for Her2 negative patients
OUTLINE
Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Courses repeat every 3 weeks Patients achieving a complete response CR receive 3 courses past CR Patients achieving a partial response or stable disease continue on therapy until CR or disease progression or unacceptable toxicity
Patients are followed for disease progression and survival Patients with HER2-negative disease are not eligible for treatment but are followed every 6 months for response and survival
I To assess the toxicity of the combination of Herceptin paclitaxel carboplatin and gemcitabine in patients with metastatic or locally recurrent urothelial cancers who overexpress HER2
SECONDARY OBJECTIVES
I The complete and partial response rates II The median and overall survival III To prospectively evaluate the percentage of patients with metastaticrecurrent bladder cancer who overexpress HER2 histologically by immunohistochemistry and FISH and serologically
IV To generate preliminary data on response to other therapy and survival for Her2 negative patients
OUTLINE
Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Courses repeat every 3 weeks Patients achieving a complete response CR receive 3 courses past CR Patients achieving a partial response or stable disease continue on therapy until CR or disease progression or unacceptable toxicity
Patients are followed for disease progression and survival Patients with HER2-negative disease are not eligible for treatment but are followed every 6 months for response and survival
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 |
|---|---|---|---|
| CDR0000067845 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17101 |
| UMCC-9955 | None | None | None |
| U01CA062487 | NIH | None | None |
| N01CM17101 | NIH | None | None |