Endometrial Cancer
Conditions
Keywords
Endometrial Cancer, Advanced Stage Endometrial Cancer, Stage 3 or 4 endometrial cancer, Cancer treatment, gyn cancer
Brief summary
Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.
Detailed description
The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.
Interventions
DRUGCarboplatin
AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
DRUGPaclitaxel
175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
DRUGbevacizumab
15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
Sponsors
Genentech, Inc.
David O'Malley
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
* Advanced Stage Endometrial Cancer (Stage 3 or 4) * Any Histology including clear cell, and serous papillary carcinomas * surgery must have had hysterectomy and bilateral salpingo-oophorectomy * chemotherapy initiated 12 weeks after surgery * sign informed consent * Adequate End-organ function * GOG (Gynecologic Oncology Group)Performance Status 0,1,2 * Patients must be 18 years or older * Patients may have received radiation for the treatment of endometrial cancer. * Patients may have measurable or non-measurable disease.
Exclusion criteria
* Patient with concomitant malignancy other than non-melanoma skin cancer * Patients with prior malignancy who have been disease free for 5 years. * Patients with serious uncontrolled infection, angina or serious peripheral neuropathy. * Patients whose circumstances will not permit study completion or adequate follow up * Patients who have received prior cytotoxic chemotherapy for treatment of endometrial cancer including chemotherapy used for radiation sensitization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Patients With Progression Free Survival (PFS) | up to 57 months | Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Estimate Overall Survival | up to 24 months | — |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability. | up to 24 months | Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0 |
| Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Up to 24 months | Tumor response will be evaluated using modified RECIST criteria with the following definitions. Complete Response (CR) is disappearance of gross evidence of disease with confirmation at least 4 weeks later. Partial Response (PR) is a 30% or greater reduction in measurement of longest dimension of each lesion with confirmation at least 4 weeks later. Progressive Disease (PD) is at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. Stable Disease (SD) is any condition not meeting the other criteria for CR, PR or PD. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carboplatin/Paclitaxel With Bevacizumab A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Carboplatin/Paclitaxel With Bevacizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| 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 | 37 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 38 |
| other Total, other adverse events | 38 / 38 |
| serious Total, serious adverse events | 4 / 38 |
Outcome results
Primary
Evaluate Patients With Progression Free Survival (PFS)
Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions.
Time frame: up to 57 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carboplatin/Paclitaxel With Bevacizumab | Evaluate Patients With Progression Free Survival (PFS) | 26 months |
Secondary
Number of Patients With Adverse Events as a Measure of Safety and Tolerability.
Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0
Time frame: up to 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboplatin/Paclitaxel With Bevacizumab | Number of Patients With Adverse Events as a Measure of Safety and Tolerability. | Patients with Adverse Event | 38 participants |
| Carboplatin/Paclitaxel With Bevacizumab | Number of Patients With Adverse Events as a Measure of Safety and Tolerability. | Patients with Serious Adverse Event | 4 participants |
Secondary
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Tumor response will be evaluated using modified RECIST criteria with the following definitions. Complete Response (CR) is disappearance of gross evidence of disease with confirmation at least 4 weeks later. Partial Response (PR) is a 30% or greater reduction in measurement of longest dimension of each lesion with confirmation at least 4 weeks later. Progressive Disease (PD) is at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. Stable Disease (SD) is any condition not meeting the other criteria for CR, PR or PD.
Time frame: Up to 24 months
Population: Two patients did not complete all 24 months of follow up and were not analyzed for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Carboplatin/Paclitaxel With Bevacizumab | Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Complete Response | 19 Participants |
| Carboplatin/Paclitaxel With Bevacizumab | Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Partial Response | 2 Participants |
| Carboplatin/Paclitaxel With Bevacizumab | Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Stable Disease | 7 Participants |
| Carboplatin/Paclitaxel With Bevacizumab | Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Progressive Disease | 1 Participants |
| Carboplatin/Paclitaxel With Bevacizumab | Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Unable to Determine | 3 Participants |
| Carboplatin/Paclitaxel With Bevacizumab | Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria | Zero Measurable Disease | 4 Participants |
Secondary
To Estimate Overall Survival
Time frame: up to 24 months
Population: Two participants did not complete all 24 months of follow-up and are were not analyzed for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carboplatin/Paclitaxel With Bevacizumab | To Estimate Overall Survival | 69.4 percentage of participants |