Phase I Trial of Oral Metronomic Topotecan and Oral Pazopanib to Treat Recurrent/Persistent Gynecologic Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00800345|
Recruitment Status : Completed
First Posted : December 2, 2008
Results First Posted : February 23, 2017
Last Update Posted : March 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Tumors||Drug: Oral Topotecan Drug: Pazopanib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Oral Metronomic Topotecan in Combination With Oral Pazopanib Utilizing a Daily Dosing Schedule to Treat Recurrent or Persistent Gynecologic Tumors|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||September 2015|
Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.
Drug: Oral Topotecan
Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
Other Name: Hycamtin capsules
Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth.
- Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 (28 days) ]
- Treatment Response [ Time Frame: After every 2 cycles of treatment beginning on Cycle 1 Day 1, up to 38 months ]Treatment response was evaluated using 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): NCT00800345
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Principal Investigator:||Todd D Tillmanns, MD||The West Clinic|