Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192101
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2005-09-12
Brief Title:
Gemcitabine Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines andor Taxanes
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Randomized Phase II Study of the Combination of Gemcitabine Gemzar Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines anor Taxanes
Status:
COMPLETED
Status Verified Date:
2007-11
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 an open label two arms randomized unblinded phase 2 study in patients with locally advanced or metastatic breast cancer who have been previously treated with anthracycline withwithout taxane based regimen in the adjuvantneoadjuvant or 1st line metastatic setting Gemcitabine will be administered via intravenous infusion over approximately 30 minutes at a dose of 1250mgm2 on days 1 and 8 of each 21-day cycle In arm ACisplatin will be given via intravenous infusion over approximately 60-120 minutes at a dose of 70 mgm2 on Day 1 of each 21-day cycle The investigator may attempt to give Cisplatin with at least one liter of fluids for hydration and on an outpatient basis
Patients will remain in the study until disease progression or when a maximum of six cycles have been administered 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 regimen if 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 additional guidelines described in the protocol After patients discontinue from study therapy they proceed to the post-study follow up phase of the study
Patients will remain in the study until disease progression or when a maximum of six cycles have been administered 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 regimen if 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 additional guidelines described in the protocol After patients discontinue from study therapy they proceed to the post-study follow up phase of the study
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-SI-S371 | None | None | None |