Platinum-sensitive Ovarian Cancer, Recurrent Ovarian Cancer
Conditions
Keywords
simvastatin
Brief summary
This is a single arm pilot trial to evaluate the feasibility of using a simvastatin intervention, and to evaluate its effects on cancer progression, among 20 patients with platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at Cedars-Sinai Medical Center.
Detailed description
This is a pilot study of statin therapy to examine the feasibility of simvastatin use to reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at Cedars-Sinai Medical Center. This study will focus on patients with recurrent platinum sensitive ovarian cancer to increase the likelihood that this population will experience recurrent disease during the 6-month intervention and follow-up. In addition, this population of patients has a narrow range of standard of care carboplatin doublet combinations that are prescribed, enabling the investigators to create a more homogenous study population. Given their high risk of developing recurrent disease, women with platinum sensitive ovarian cancer, have the potential to derive the maximum benefit from an intervention that could delay disease progression and enhance survival.
Interventions
DRUGSimvastatin 40mg
Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin
Sponsors
Marc Goodman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid, mucinous, clear cell). Platinum sensitivity defined as ≥ 6 months since last platinum treatment. * No contraindication to carboplatin and/or liposomal doxorubicin or simvastatin.
Exclusion criteria
* Prior or current use of any statin medication * Current systemic use of medications known to interact with statins * Current use of any other investigational agents * Liver disease, active cirrhosis * Uncontrolled intercurrent illness * History of chronic myopathy * Prior cancer other than ovarian cancer or non-melanomatous skin cancers * Known active infection with HIV * Current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day) * Prior exposure to doxorubicin or liposomal doxorubicin * Hemoglobin A1C \>8.0%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of the simvastatin intervention with at least 85% compliance | From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days) | Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response by CA125 | From baseline until 12 months | Change in serum level of CA125 |
| Progression-free survival | From baseline until 12 months | Duration until disease progression or death |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBobbie Jo Rimel, MD
Cedars-Sinai Medical Center
Outcome results
None listed