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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00055 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| GYN-067 | Other Identifier | Fox Chase Cancer Center |
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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
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of RAD001 (everolimus) in combination with carboplatin and PLD.
SECONDARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | See Detailed Description |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD of RAD001 in combination with carboplatin and pegulated liposomal doxorubicin | 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. | About 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/tolerability of the three drug combination of carboplatin, PLD and RAD001 based on Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | 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. | Every 28 days and when patient is removed from study for any reason |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gina Martina-Smaldone, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
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| carboplatin | Drug | Given IV |
|
|
| pegylated liposomal doxorubicin hydrochloride | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Preliminary analysis of anti-tumor activity of this regimen in patients with recurrent ovarian, fallopian tube or primary peritoneal cancers | Baseline and every 28 days |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D016190 | Carboplatin |
| C506643 | liposomal doxorubicin |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D056831 | Coordination Complexes |
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