Phase 2
N=32
Neoadjuvant Therapy for Ovarian Cancer
Epithelial Ovarian Cancer · Primary Peritoneal Cancer · Fallopian Tube Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01146795 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
Feb 2021
Primary outcome: Primary: Number of Protocol Defined Adverse Events in Patients Receiving Neoadjuvant Carboplatin, Paclitaxel, and Bevacizumab — 7 protocol defined adverse events
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
- Jason D. Wright
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Protocol Defined Adverse Events in Patients Receiving Neoadjuvant Carboplatin, Paclitaxel, and Bevacizumab |
7 | — |
| SECONDARY Response Rate |
6.5; 71.0; 22.6 | — |
| SECONDARY Quality of Life (QOL) Score |
6; 7.4; 8.9; 6.6 | — |
| SECONDARY Progression-free Survival (PFS) |
16.8 | — |
Summary
This study is to determine the feasibility of administering neoadjuvant carboplatin, paclitaxel, and bevacizumab without excessive dose modification or cycle delay in patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. This study will also investigate the rate of optimal cytoreduction, response rate and progression free and overall survival, and to assess the quality of life for patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer treated with neoadjuvant carboplatin, paclitaxel and bevacizumab.
Eligibility Criteria
Inclusion Criteria
- Patients must have Suspected Federation of Gynecology and Obstetrics (FIGO) stage III or IV disease.
- Cytologic or histologic diagnosis of a carcinoma felt by the investigator to be compatible with epithelial cancer of the ovary, fallopian tube, or primary peritoneum
- Patients must have a Performance Status of 0, 1 or 2.
- Patients with prior anthracycline exposure must have a baseline multigated acquisition scan (MUGA) or echocardiogram prior to study entry.
- Patients must have adequate:
- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1500/υl, equivalent to Common Toxicity Criteria for Adverse Events v3.0 (CTCAE) Grade 1. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.
- Platelets greater than or equal to 100,000/υl (CTCAE Grade 0-1).
- Hematocrit > 21%.
- Renal function: Creatinine 140 mm Hg or diastolic > 90 mm Hg.
- Myocardial infarction or unstable angina within 6 months of day 1 prior to registration.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- Serious cardiac arrhythmia requiring medication. This does not include atrial fibrillation.
- CTCAE Grade 3 or greater peripheral vascular disease.
- History of CVA within six months.
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies including hypersensitivity to any component of bevacizumab
- Patients with clinically significant proteinuria. Urine protein should be screened by urine protein-creatinine ratio (UPCR). The UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection. Specifically, a UPCR of 1.0 is equivalent to 1.0 grams of protein in a 24 hour urine collection. Obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine). Send sample to lab with request for urine protein and creatinine levels (separate requests). The lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL). The UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL). Patients must have a UPCR < 1.0 to allow participation in the study.
- Patients with hypertensive crises or hypertensive encephalopathy
- History of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within 1 month prior to day 1.
- Patients with or with anticipation of a non-study related invasive procedure defined as followed:
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab.
- Major non-study related surgical procedure anticipated during the course of the study.
- Core biopsy within 7 days prior to first date of bevacizumab.
- Patients with a Performance Status of Grade 3 or 4 are not eligible.
- Patients who are pregnant or nursing. Subjects of child-bearing age have to use effective means of contraception.
- Patients under the age of 18.
- Patients who have received prior therapy with any anti-VEGF drug, including bevacizumab. Vascular endothelial growth factor (VEGF)
- Patients with human immunodeficiency virus (HIV).
- Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study. The investigator should consult the Study Chair.
Data sourced from ClinicalTrials.gov (NCT01146795). 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.