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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470067 |
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with carboplatin works in treating patients with recurrent, stage III, or stage IV primary endometrial cancer.
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: carboplatin Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multi-Center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma |
Estimated Enrollment: | 37 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary endometrial carcinoma meeting 1 of the following criteria:
Measurable disease
PATIENT CHARACTERISTICS:
No cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Shashikant B. Lele, MD | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute Amherst Center ( Shashikant B. Lele ) |
Study ID Numbers: | CDR0000543389, RPCI-I-68005 |
Study First Received: | May 3, 2007 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00470067 History of Changes |
Health Authority: | United States: Federal Government |
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma |
Genital Diseases, Female Anti-Bacterial Agents Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms |
Endometrial Cancer Urogenital Neoplasms Carboplatin Doxorubicin Recurrence Carcinoma |
Antineoplastic Agents Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Carboplatin Antibiotics, Antineoplastic Pharmacologic Actions |
Doxorubicin Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Uterine Neoplasms |