Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Avastin
|
Drug: Avastin
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
Other Names:
Drug: Paclitaxel
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
Drug: Cisplatin
75mg/m2 IP day 2 every 21 days x 6 cycles
|
Outcome Measures
Primary Outcome Measures
- Number of Patients Able to Complete 6 Cycles of Treatment. [2 years]
Completion of cycle 6
Secondary Outcome Measures
- Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin. [2 years]
CTCAE assessment of toxicity
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
Sponsors and Collaborators
- University of Oklahoma
- Genentech, Inc.
Investigators
- Principal Investigator: D. Scott McMeekin, MD, University of Oklahoma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2674
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Avastin |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 20 |
| COMPLETED | 13 |
| NOT COMPLETED | 7 |
Baseline Characteristics
| Arm/Group Title | Avastin |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 20 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
14
70%
|
| >=65 years |
6
30%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
59
|
| Sex: Female, Male (Count of Participants) | |
| Female |
20
100%
|
| Male |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
3
15%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
16
80%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
1
5%
|
| Region of Enrollment (Count of Participants) | |
| United States |
20
100%
|
Outcome Measures
| Title | Number of Patients Able to Complete 6 Cycles of Treatment. |
|---|---|
| Description | Completion of cycle 6 |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Avastin |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 20 |
| Count of Participants [Participants] |
17
85%
|
| Title | Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin. |
|---|---|
| Description | CTCAE assessment of toxicity |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Avastin |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 20 |
| Count of Participants [Participants] |
2
10%
|
Adverse Events
| Time Frame | 6 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Avastin | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Avastin | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Serious Adverse Events |
||
| Avastin | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/20 (5%) | |
| Renal and urinary disorders | ||
| Entero-vesical fistula | 1/20 (5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Avastin | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/20 (10%) | |
| General disorders | ||
| Grade 3 abdominal pain | 1/20 (5%) | 1 |
| Nervous system disorders | ||
| Grade 3 Neurpoathy | 1/20 (5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ingrid Block, CTO Director |
|---|---|
| Organization | University of Oklahoma |
| Phone | 405 271-8001 |
| ingrid-block@ouhsc.edu |
- 2674