A Study of Carboplatin, PLD and Everolimus in Certain Gynecologic Cancer
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|ClinicalTrials.gov Identifier: NCT01281514|
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : July 11, 2019
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pegylated liposomal doxorubicin hydrochloride (PLD) work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboplatin and PLD together with everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with carboplatin and PLD in treating patients with relapsed ovarian epithelial, fallopian tube, or peritoneal cavity cancer
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer||Drug: everolimus Drug: carboplatin Drug: pegylated liposomal doxorubicin hydrochloride Other: laboratory biomarker analysis||Phase 1|
I. Determine the maximum tolerated dose (MTD) of RAD001 (everolimus) in combination with carboplatin and PLD.
I. Determine safety/tolerability of the three drug combination of carboplatin, PLD and RAD001 (everolimus).
II. Determine preliminary analysis of anti-tumor activity of this regimen in patients with recurrent ovarian, fallopian tube or primary peritoneal cancers.
OUTLINE: This is a dose-escalation study of everolimus.
Patients receive carboplatin intravenously (IV) and PLD IV on day 1 and everolimus orally (PO) once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Everolimus in Patients With Platinum-Sensitive Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer in First Relapse|
|Actual Study Start Date :||December 14, 2010|
|Actual Primary Completion Date :||January 8, 2018|
|Actual Study Completion Date :||January 8, 2018|
See Detailed Description
Drug: pegylated liposomal doxorubicin hydrochloride
Other: laboratory biomarker analysis
- MTD of RAD001 in combination with carboplatin and pegulated liposomal doxorubicin [ Time Frame: About 24 weeks ]Determine the MTD of RAD001 (everolimus) in combination with carboplatin and pegylated liposomal doxorubicin. The MTD is defined as the dose level closest to, but not over that which is predicted to result in a DLT rate of 30%, the target toxicity.
- Safety/tolerability of the three drug combination of carboplatin, PLD and RAD001 based on Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Every 28 days and when patient is removed from study for any reason ]Determine safety/tolerability of the three drug combination of carboplatin, PLD and RAD001. Determine preliminary analysis of anti-tumor activity of this regimen in patients with recurrent ovarian, fallopian tube or primary peritoneal cancers.
- Preliminary analysis of anti-tumor activity of this regimen in patients with recurrent ovarian, fallopian tube or primary peritoneal cancers [ Time Frame: Baseline and every 28 days ]
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): NCT01281514
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Gina Martina-Smaldone, MD||Fox Chase Cancer Center|