Advanced Ovarian Carcinoma, Ovarian Carcinosarcoma, Primary Peritoneal Carcinoma
Conditions
Keywords
Ovarian Cancer, Gynecologic Cancer, Ovarian Carcinoma, Peritoneal Carcinoma, IP chemotherapy, Intraperitoneal, Avastin, Bevacizumab
Brief summary
The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.
Detailed description
Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses. Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.
Interventions
DRUGAvastin
Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles
DRUGPaclitaxel
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
DRUGCisplatin
75mg/m2 IP day 2 every 21 days x 6 cycles
Sponsors
Genentech, Inc.
University of Oklahoma
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 with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma. * Adequate bone marrow, renal, and hepatic function * Patients must be entered no more than twelve weeks postoperatively
Exclusion criteria
* Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas). * Stage IV or suboptimally debulked disease following primary cytoreductive surgery * Patients who have received prior radiotherapy or chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Able to Complete 6 Cycles of Treatment. | 2 years | Completion of cycle 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin. | 2 years | CTCAE assessment of toxicity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Avastin Avastin: Initial Treatment:
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Consolidation Treatment:
Avastin 15mg/kg IV every 21 days x 12 cycles | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Avastin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 1 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Number of Patients Able to Complete 6 Cycles of Treatment.
Completion of cycle 6
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Avastin | Number of Patients Able to Complete 6 Cycles of Treatment. | 17 Participants |
Secondary
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.
CTCAE assessment of toxicity
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Avastin | Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin. | 2 Participants |