Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
recurrent, persistent
Brief summary
Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib is a novel agent has recently been approved for the treatment of subjects with advanced renal cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for recurrent or persistent ovarian cancer. This is an open label study in which subjects will be randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib. Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle. Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All subjects will be monitored for toxicity and other indicators of safety (labs, physical exams, vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5 years following the conclusion of treatment to evaluate efficacy. The primary endpoints of the study are progression free survival and overall survival, which will be assessed at three years.
Interventions
DRUGGemcitabine
Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
DRUGpazopanib
Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
Sponsors
Novartis
Linda R Duska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be at least 18 years old * Must have measurable or detectable ovarian, fallopian or primary peritoneal cancer * Must have been treated previously with carboplatin, cisplatin or another organoplatinum compound
Exclusion criteria
* Women who are pregnant or nursing * History of congenital long QT syndrome * Active bleeding or at risk of a bleeding disorder * Other significant medical condition or history of medical condition which may put the patient at risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 3 years | Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of recurrence/progression or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 30 days after last dose | Adverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days. | 73 |
| Gemcitabine + Pazopanib Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles | 75 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 30 |
Baseline characteristics
| Characteristic | Gemcitabine | Total | Gemcitabine + Pazopanib |
|---|---|---|---|
| Age, Continuous | 62 years | 63 years | 63 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 19 Participants | 10 Participants |
| Race (NIH/OMB) White | 58 Participants | 115 Participants | 57 Participants |
| Region of Enrollment United States | 73 participants | 148 participants | 75 participants |
| Sex: Female, Male Female | 73 Participants | 148 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 54 / 73 | 63 / 75 |
| other Total, other adverse events | 73 / 73 | 75 / 75 |
| serious Total, serious adverse events | 20 / 73 | 63 / 75 |
Outcome results
Primary
Progression-free Survival
Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of recurrence/progression or death from any cause, whichever occurs first.
Time frame: 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine | Progression-free Survival | 2.9 months |
| Gemcitabine + Pazopanib | Progression-free Survival | 5.3 months |
p-value: 0.01995% CI: [0.61, 1.07]non-parametric weighted Tarone-Ware test
Secondary
Number of Participants With Adverse Events
Adverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment
Time frame: 30 days after last dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gemcitabine | Number of Participants With Adverse Events | 73 Participants |
| Gemcitabine + Pazopanib | Number of Participants With Adverse Events | 75 Participants |