Phase 2
Completed N=60
Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer
Source: ClinicalTrials.gov NCT00369122 ↗Enrolled (actual)
60
Serious AEs
22.0%
Results posted
May 2013
Primary outcomePrimary: Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start. — 0; 15 participants
Summary
This phase II trial is studying how well giving bevacizumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cervical cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and cisplatin may kill more tumor cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start. |
0; 15 | — |
| SECONDARY Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time. |
0; 18 | — |
| SECONDARY Disease-free Survival (Three-year Rate Reported) |
68.7 | — |
| SECONDARY Overall Survival (Three-year Rate Reported) |
81.3 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed squamous cell, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix, meeting 1 of the following stage criteria:
- Stage IIB-IIIB lymph nodes
- Stage IB-IIA disease with biopsy-proven pelvic node metastases and/or tumor size >= 5 cm
- No positive para-aortic lymph nodes
- Zubrod performance status 0-2
- WBC >= 3,000/mm^3
- Absolute granulocyte count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- INR = 10 g/dL (transfusion allowed)
- Urine protein: creatinine ratio ? 0.5 OR urine protein = 3 years
- No significant traumatic injury within the past 28 days
- No clinically significant cardiovascular disease, such as the following:
- Uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication)
- Myocardial infarction within the past 12 months
- Unstable angina within the past 12 months
- New York Heart Association class II-IV congestive heart failure
- Unstable symptomatic arrhythmia requiring medication (i.e., chronic atrial arrhythmia, atrial fibrillation, or paroxysmal supraventricular tachycardia)
- Arterial thromboembolic events, including transient ischemic attack or clinically significant peripheral artery disease, within the past 6 months
- Arterial thromboembolic events, including transient ischemic attack or clinically significant peripheral artery disease, within the past 6 months
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No known HIV
- No prior organ transplant
- No prior surgery for carcinoma of the cervix other than biopsy
- No prior surgical debulking of pelvic or para-aortic nodes
- No prior pelvic radiotherapy, including transvaginal irradiation to control bleeding
- No prior systemic chemotherapy
- No major surgical procedure or open biopsy within the past 28 days or anticipation of need for major surgical procedure during the course of the study
- No fine needle aspirations or core biopsies within the past 7 days
- No concurrent major surgical procedure
- No concurrent epoetin alfa or Hypericum perforatum (St. John's wort)
- No concurrent intensity-modulated radiotherapy
- No concurrent transvaginal irradiation to control bleeding
Data sourced from ClinicalTrials.gov (NCT00369122). 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. Informational only — not medical advice.