Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00097383
Collaborator
(none)
26
Study Details
Study Description
Brief Summary
This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of locally advanced or metastatic breast cancer not amenable to local treatment.
-
Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.
-
Patients must have at least one measurable lesion in an area not previously irradiated.
-
No chemotherapy at least 4 weeks prior to study enrollment.
-
Signed informed consent from patient.
Exclusion Criteria:
-
Treatment with any drug within the last 30 days that has not received regulatory approval.
-
Serious systemic disorders, including active infection.
-
Significant cardiovascular disease.
-
Pregnancy or breast feeding.
-
Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | La Plata | Buenos Aires | Argentina | |
| 2 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Rosario | Santa Fe | Argentina | |
| 3 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Buenos Aires | Argentina | ||
| 4 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Ciudad De Buenos Aires | Argentina | ||
| 5 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Brussels | Belgium | ||
| 6 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Leuven | Belgium | ||
| 7 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Wilrijk | Belgium | ||
| 8 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Maceio | AL | Brazil | |
| 9 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Belo Horizonte | BH | Brazil | |
| 10 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Curitiba | PR | Brazil | |
| 11 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Porto Alegre | RS | Brazil | |
| 12 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Sao Paulo | Sao Paulo/SP | Brazil | |
| 13 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Sao Paulo | SP | Brazil | |
| 14 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Sorocaba | SP | Brazil | |
| 15 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Sao Paulo | Brazil | ||
| 16 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Guadalajara | Jalisco | Mexico | |
| 17 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Mexico | Mexico D.F. | Mexico | |
| 18 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Col. Campestre Churubusco | Mexico | ||
| 19 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Mexico City | Mexico | ||
| 20 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Arquiparque-Miraflores | Alges | Portugal | |
| 21 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Coimbra | Portugal | ||
| 22 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Lisboa | Portugal | ||
| 23 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Porto | Portugal | ||
| 24 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Proto | Portugal | ||
| 25 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Santa Maria Da Feira | Portugal | ||
| 26 | For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. | Santarem | Portugal |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00097383
Other Study ID Numbers:
- 4028
- H3E-MC-JMDU
First Posted:
Nov 23, 2004
Last Update Posted:
Jul 19, 2006
Last Verified:
Jul 1, 2006