Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer
Sponsor: Pharmatech Oncology
Listed as NCT00027989, this PHASE2 trial focuses on Breast Cancer and remains ongoing. Sponsored by Pharmatech Oncology, it has been updated 6 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)OBJECTIVES:
* Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine.
* Determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen.
* Determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses beyond documentation of CR.
Quality of life is assessed at baseline, on day 1 of each course, and then at the end of study.
Patients are followed at 4 weeks and then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
OBJECTIVES:
* Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine. * Determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. * Determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses beyond documentation of CR.
Quality of life is assessed at baseline, on day 1 of each course, and then at the end of study.
Patients are followed at 4 weeks and then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Unknown PHASE2
-
Sep 2024 — Present [monthly]
Unknown PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE2
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE2
▶ Show 1 earlier version
-
Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE2
First recorded
Dec 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Pharmatech Oncology
For direct contact, visit the study record on ClinicalTrials.gov .