Breast Cancer Clinical Trial
Official title:
A Phase 2 Study of ALIMTA Plus Doxorubicin Administered Every 21 Days in Patients With Advanced Breast Cancer
This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin 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. However, there is no guarantee that the patient will benefit from this treatment.
| Status | Completed |
| Enrollment | 77 |
| Est. completion date | October 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of locally advanced or metastatic breast cancer that is not amenable to local treatment. - Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy. - At least one measurable lesion. - No chemotherapy within 4 weeks prior to enrollment. - Signed informed consent from the patient. Exclusion Criteria: - Prior chemotherapy for metastatic breast cancer. - Prior treatment with any anthracyclines or anthracenedione-containing regimen. - Treatment within the last 30 days with any drug that has not received regulatory approval. - Pregnancy and/or breast feeding. - Inability or unwillingness to take folic acid or vitamin B12 supplementation. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Belo Horizonte | BH |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Rio de Janeiro | |
| Brazil | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Sao Paulo | |
| Greece | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Athens | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Budapest | |
| Hungary | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Szekesfehervar | |
| Peru | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Lima | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Krakow | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Lodz | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Madrid | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Valencia | |
| Venezuela | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Caracas |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
Brazil, Greece, Hungary, Peru, Poland, Spain, Venezuela,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate | |||
| Secondary | Time to progressive disease | |||
| Secondary | Progression-free survival | |||
| Secondary | Overall survival |
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