Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192062
Status:
COMPLETED
Last Update Posted:
2007-08-31
First Post:
2005-09-12
Brief Title:
A Trial of Gemcitabine Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase II Trial of Gemcitabine Gemzar Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-08
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:
This is a Phase II study of gemcitabine- Vinorelbine combination in a 3-weekly schedule as first line chemotherapy in patients with metastatic breast cancer Eighty patients with measurable disease will be enrolled in the study Gemcitabine will be used at 1000 mgm2 vinorelbine at 25mgm2 Every cycle vinorelbine will be administered before gemcitabine After the initial dose modifications of Gemcitabine and vinorelbine doses are allowed based on patient toxicity
Study therapy may continue until
There is evidence of progressive disease
The patient experiences unacceptable toxicity
The investigator decides that the patient should be discontinued
The patient requests discontinuation
The patient has received 6 cycles of the regimenif the physician decides to continue after 6 cycles-this will be done after consultation with the sponsor
Discontinuation from study therapy is indicated according to the protocol Its the investigators responsibility to strictly stick to the protocol procedures It needs to be discussed with Lilly medical designee in advance when any special situation occurs which has not been defined in protocol
After patients discontinue from study therapy they proceed to the post-study follow up phase of the study Assessments to take place during this phase are outlined in the protocol
Study therapy may continue until
There is evidence of progressive disease
The patient experiences unacceptable toxicity
The investigator decides that the patient should be discontinued
The patient requests discontinuation
The patient has received 6 cycles of the regimenif the physician decides to continue after 6 cycles-this will be done after consultation with the sponsor
Discontinuation from study therapy is indicated according to the protocol Its the investigators responsibility to strictly stick to the protocol procedures It needs to be discussed with Lilly medical designee in advance when any special situation occurs which has not been defined in protocol
After patients discontinue from study therapy they proceed to the post-study follow up phase of the study Assessments to take place during this phase are outlined in the protocol
Detailed Description:
None
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 |
|---|---|---|---|
| B9E-EY-S372 | None | None | None |