Phase II Study of Pazopanib and Topotecan in Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT02348398|
Recruitment Status : Withdrawn
First Posted : January 28, 2015
Last Update Posted : August 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: Pazopanib Drug: Topotecan Behavioral: Phone Call||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pazopanib and Oral Topotecan in Women With Recurrent Cervical Cancer|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2019|
Experimental: Pazopanib + Topotecan
Pazopanib 600 mg taken orally continuously while Topotecan 0.25 mg taken orally for 21 days continuously followed by 7 days off. A cycle will be defined as 28 days.
During follow up if disease gets worse, participant called by study staff every 3 months.
600 mg by mouth daily in a 28 day cycle.
Other Name: GW786034
0.25 mg by mouth daily for 21 days of a 28 day cycle.
Other Name: Hycamtin
Behavioral: Phone Call
During follow up if disease gets worse, participant called by study staff every 3 months. Each call should last about 5 minutes.
- Objective Tumor Response [ Time Frame: 6 months ]Duration of overall response measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Duration of overall CR is measured from the time measurement criteria are first met for CR until first date that recurrent disease is objectively documented. Complete Response (CR): Disappearance of all target lesions. Any pathologic lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
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): NCT02348398
|Principal Investigator:||Michael M. Frumovitz, MD, MPH||M.D. Anderson Cancer Center|