Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
ovarian cancer, platinum sensitive cancer, fallopian tube cancer, peritoneal cancer
Brief summary
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.
Detailed description
In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.
Interventions
DRUGBevacizumab
Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
DRUGGemcitabine
A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
DRUGCarboplatin
Sponsors
Genentech, Inc.
Eli Lilly and Company
Ohio State University Comprehensive Cancer Center
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
* Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment. * Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present. * History of at least one therapy of platinum based chemotherapy.
Exclusion criteria
* Participation in another experimental drug study * Heart disease or high blood pressure * History of a stroke within the past 6 months * Vascular disease, or bleeding problems * Brain cancer * Major Surgical Procedure within 28 days prior to start date * Minor surgical procedures within 7 days prior to start date * Pregnant or lactating * Abdominal or bowel problems like bleeding * History of abdominal fistula, GI perforation or Intra-abdominal abscess * Serious, non-healing wound, ulcer or bone fracture * Acute hepatitis * Active infections requiring antibiotics * Inability to comply with study or follow up procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding. | up to 6 months | Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival for Patients Treated With the Regimen. | To progression of Disease | The period of time from study entry until disease progression or date of last contact. |
Countries
United States
Participant flow
Recruitment details
February 2006 through August 2010
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine/Carboplatin/Bevacizumab A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administred on day 1 and day 15 of a 28 day cycle
Carboplatin | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Gemcitabine/Carboplatin/Bevacizumab |
|---|---|
| Age, Continuous | 60.0 years |
| Disease status at study enrollment Measurable disease | 33 patients |
| Disease status at study enrollment Non-measurable disease (CA125) | 12 patients |
| ECOG (Eastern Cooperative Oncology Group) Performance Status 0 (Fully active) | 34 patients |
| ECOG (Eastern Cooperative Oncology Group) Performance Status 1 (Restricted in physical activity) | 11 patients |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Platinum-free interval | 15 months |
| Primary disease grade G2(tissue moderately differentiated) | 3 patients |
| Primary disease grade G3(tissue poorly differentiated/undifferentiated) | 42 patients |
| Primary disease site Ovarian | 40 patients |
| Primary disease site Primary peritoneal | 4 patients |
| Primary disease site Tubal | 1 patients |
| Primary disease stage Stage 1-2 (cancer located in ovaries or pelvis) | 7 patients |
| Primary disease stage Stage 3 (cancer in ovaries spread to peritoneum) | 34 patients |
| Primary disease stage Stage 4 (cancer has spread to distant organs) | 4 patients |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 6 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 45 patients |
| Sex: Female, Male Female | 45 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 | 39 / 45 |
| serious Total, serious adverse events | 4 / 45 |
Outcome results
Primary
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
Time frame: up to 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine/Carboplatin/Bevacizumab | Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding. | 13.3 months |
Secondary
Overall Survival for Patients Treated With the Regimen.
The period of time from study entry until disease progression or date of last contact.
Time frame: To progression of Disease
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine/Carboplatin/Bevacizumab | Overall Survival for Patients Treated With the Regimen. | 36.1 months |