Phase 3
N=452
Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Cervical Adenocarcinoma · Cervical Adenosquamous Carcinoma · Cervical Squamous Cell Carcinoma · Recurrent Cervical Carcinoma · Stage IVB Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00803062 ↗Enrolled (actual)
452
Serious AEs
44.0%
Results posted
May 2016
Primary outcome: Primary: Overall Survival — 14.26; 17.51; 12.68; 16.20 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bevacizumab (Biological); Cisplatin (Drug); Laboratory Biomarker Analysis (Other); Paclitaxel (Drug); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Topotecan Hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
14.26; 17.51; 12.68; 16.20 | — |
| PRIMARY Progression-free Survival |
6.67; 9.63; 5.29; 7.36 | — |
| PRIMARY Tumor Response |
44.74; 49.57; 27.03; 47.32 | — |
| PRIMARY To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study. |
34; 48; 48; 66; 6; 5 | — |
Summary
This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.
Eligibility Criteria
Inclusion Criteria
- Patients must have primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
- All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT; biopsy confirmation is required if the lesion(s) measures = 1500/mcl
- Platelets >= 100,000/mcl
- Serum creatinine = = 60 ml/min
- Bilirubin = 150 mm Hg or diastolic > 90 mm Hg
- Myocardial infarction or unstable angina < 6 months prior to registration
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
- CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours (hrs)]) episodes of ischemia managed non-surgically and without permanent deficit)
- History of CVA within six months
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- Patients with or with anticipation of invasive procedures as defined below:
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy
- Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures
- Core biopsy, within 7 days prior to randomization
- Patients who are pregnant or nursing; bevacizumab should not be administered to pregnant women; bevacizumab should not be administered to nursing women; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
- Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
- Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
- 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 feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard
- Patients with significant peripheral vascular disease
- Patients with pre-existing grade 2 or greater peripheral neuropathy
Data sourced from ClinicalTrials.gov (NCT00803062). 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.