Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT00055614|
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : June 26, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: topotecan hydrochloride Procedure: adjuvant therapy||Phase 1|
- Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression.
Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients.
Patients are followed every 2 months for at least 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Official Title:||Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)|
|Study Start Date :||May 2002|
|Actual Study Completion Date :||October 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055614
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Stephen A. Cannistra, MD||Beth Israel Deaconess Medical Center|