Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma
Conditions
Keywords
Recurrent, ovarian, fallopian tube, primary peritoneal, cancer, Recurrent ovarian, fallopian tube, primary peritoneal cancer
Brief summary
This study will investigate the efficacy as well as the safety of RAD001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be taken orally once daily and bevacizumab will be administered once every 14 days. The study will be conducted over a period of about 3 to 4 years.
Detailed description
In this trial, approximately 50 patients will receive the study drug, RAD001 in combination with bevacizumab (Avastin)chemotherapy. RAD001 will be taken orally once daily and bevacizumab will be administered intravenously once every 14 days. In addition to study treatment, a few blood samples and a sample of the patients tumor from a previous surgery if available will be collected for research.
Interventions
DRUGRAD001
RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal.
DRUGbevacizumab
bevacizumab will be administered intravenously (IV) once every 14 days.
Sponsors
Novartis Pharmaceuticals
Genentech, Inc.
University of Pittsburgh
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
* Patients may or may not have measurable disease. Measurable disease is defined according to RECIST criteria. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation was completed. * Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy) * Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. * Performance status £ 2 * Signed informed consent.
Exclusion criteria
* Prior treatment with any investigational drug within the preceding 4 weeks * Chronic treatment with systemic steroids or another immunosuppressive agent * Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period * Uncontrolled brain or leptomeningeal metastases * Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation * Uncontrolled diabetes mellitus * A known history of HIV seropositivity * Impairment of gastrointestinal function or gastrointestinal disease * Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin) * Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. * Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus). * Patients with a known hypersensitivity to RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus) or excipients, or bevacizumab * Patients with serious non-healing wound, ulcer, or bone fracture. * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) at 6-months | Up to 36 months (data collection period for the cohort); Up to 6 months for participant | The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) | Within 4 weeks (28 days) of study treatment initiation (baseline) | The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RAD001 + Bevacizumab Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | RAD001 + Bevacizumab |
|---|---|
| Age, Continuous | 60.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 50 |
| serious Total, serious adverse events | 19 / 50 |
Outcome results
Primary
Progression-free Survival (PFS) at 6-months
The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Time frame: Up to 36 months (data collection period for the cohort); Up to 6 months for participant
Population: Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAD001 + Bevacizumab | Progression-free Survival (PFS) at 6-months | 28 percentage of participants |
Secondary
Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)
The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Time frame: Within 4 weeks (28 days) of study treatment initiation (baseline)
Population: Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days + imaging every 8-12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RAD001 + Bevacizumab | Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) | 4 participants |