Phase I Trial of Oral Metronomic Topotecan and Oral Pazopanib to Treat Recurrent/Persistent Gynecologic Tumors
This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Determine the MTD of metronomic oral topotecan in combination with oral pazopanib for future phase II evaluation. [ Time Frame: every 28 days ] [ Designated as safety issue: Yes ]
- Identification and incidence of AEs and SAEs. [ Time Frame: every 28 days ] [ Designated as safety issue: Yes ]
- Potential signals for response per RECIST criteria. [ Time Frame: after every 2 cycles ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Metronomic oral topotecan will be administered by mouth beginning on Cycle 1 Day 1. Oral pazopanib will not be administered on Cycle 1 Day 1 to allow for the characterization of topotecan pharmacokinetics; pazopanib will be administered by mouth beginning on Cycle 1 Day 2. The 1st 3 patients enrolled receiving oral topotecan 0.50 mg QD and oral pazopanib 400 mg QD. 3 patients will be enrolled at dose level 1 and observed for DLT(s) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s).
Drug: Oral Topotecan
Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.
Other Name: HycamtinDrug: Pazopanib
Starting on Cycle 1 Day 2, each subject will receive the assigned dose of pazopanib administered by mouth.
Other Name: GW786034
This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors. The study will include a Screening Phase, a Treatment Phase and a Followup Phase. In the Screening Phase the subject's eligibility for study participation will be determined; this phase can last up to 28 days. The Treatment Phase will begin when the subject starts study treatment and will continue until the subject is removed from study treatment. The Follow-up Phase will last for 30 days after the subject ends study treatment. The study will be conducted at approximately 1 Accelerated Community Oncology Research Network, Inc.(ACORN) site and will include approximately 9-20 evaluable patients. Treatment cycle length is 28 days. During cycle 1, patients will have assessments done on days 1, 8, and 15. During cycle 2 and in subsequent cycles, patients will have assessments done on days 1 and 15. The patient may be evaluated more frequently as needed to manage toxicities or per investigator discretion. Radiologic imaging will be repeated after every 2 cycles.
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Principal Investigator:||Todd D Tillmanns, MD||The West Clinic|