Phase 2
N=38
Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00513786 ↗Enrolled (actual)
38
Serious AEs
10.5%
Results posted
Mar 2025
Primary outcome: Primary: Evaluate Patients With Progression Free Survival (PFS) — 26 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Paclitaxel (Drug); bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- David O'Malley
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Patients With Progression Free Survival (PFS) |
26 | — |
| SECONDARY To Estimate Overall Survival |
69.4 | — |
| SECONDARY Number of Patients With Adverse Events as a Measure of Safety and Tolerability. |
38; 4 | — |
| SECONDARY Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria |
19; 2; 7; 1; 3; 4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00513786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.