Oral Topotecan to Treat Recurrent or Persistent Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00382733|
Recruitment Status : Completed
First Posted : September 29, 2006
Results First Posted : July 18, 2013
Last Update Posted : July 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Tumors||Drug: Oral Topotecan||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Topotecan, Utilization for a Metronomic Dosing Schedule to Treat Recurrent or Persistent Solid Tumors|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Drug: Oral Topotecan
- Maximum Tolerated Dose (MTD) of Single Agent Metronomic Oral Topotecan [ Time Frame: MTD was assessed during the first cycle of treatment (days 1-28). ]The MTD of metronomic oral topotecan was determined using a standard 3+3 dose escalation cohort design. The total sample and the number of subjects who receive each dose in this design depends on the frequency of dose limiting toxicities (DLTs)at each dose level. If 0 out of 3 subjects experience a DLT at a given dose level, 3 subjects will be enrolled at the next higher dose level. If greater than or equal to 2 subjects experience a DLT at a given dose level, dose escalation will be stopped. If 1 out of 3 subjects experience a DLT at a given dose level, 3 subjects are enrolled at the same dose level.
- Dose Limiting Toxicities (DLT) [ Time Frame: DLTs were assessed during the first cycle of treatment (days 1-28). ]DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. This measure reports the number of subjects who experienced DLT at each dose level during the dose finding portion of the study.
- Best Overall Response [ Time Frame: Best overall response was assessed after every 8 weeks of treatment and at the end of treatment or time of disease progression, up to 1 year. ]Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of disease progression. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
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): NCT00382733
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Principal Investigator:||Todd D. Tillmanns, M.D.||West Clinic|