Clinical trial · Interventional
Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer
Phase II Trial of Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer
NCT00548418CI-TRIAL-00015282completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the combination of topotecan, cisplatin and bevacizumab is effective in the treatment of recurrent or persistent cervical cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- I
- description
- Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle Bevacizumab 15 mg/kg day 1 of a 21 day cycle
- interventionNames
- Drug: Topotecan
- Drug: Cisplatin
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Anti-tumor Activity as Measured by Surviving Progression-free
- timeFrame
- Progression-free survival at 6 months
- description
- Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.
Secondary outcomes (4)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent or persistent squamous, adenosquamous or adenocarcinoma of the uterine cervix not amenable to curative treatment with surgery and/or radiotherapy * No prior therapy (radiation, chemotherapy, hormonal therapy or immunotherapy) for recurrence or persistence. May have received platinum in combination with radiation as part of up-front treatment or adjuvant treatment * Must have measurable disease as defined by RECIST criteria * Must have at least one "target lesion" to assess response * Performance status of 0 or 1 * Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry * At least 4 weeks must have elapsed since prior treatment * Age \>= 18 years * Patients of childbearing potential must have a negative pregnancy test, use effective means of contraception * Signed informed consent * Bone marrow function: ANC \>= 1500/ul; platelets \>= 100,000 /ul * Renal function: creatinine \<= 1,5 X ULN (if \> 1.5 creatinine clearance must be \> 60 ml/min) * Hepatic function: bilirubin \<= 1.5 X ULN, AST and alkaline phosphatase \<= 2.5 X ULN * Neurologic function: neuropathy \< CTC grade 1 * Coagulation: PT INR \<= 1.5 Exclusion Criteria: * Evidence of sepsis or severe infection * Prior therapy for recurrence * Patients with serious, non-healing wound, ulcer or bone fracture * Patients with history or evidence of nervous system disease, including primary brain tumor, brain metastases, seizure not controlled with standard medical therapy, CVA, stroke, TIA or subarachnoid hemorrhage within 6 months of 1st date of treatment on study * Patients with history of other invasive malignancy (treatment within last 5 years) other than non-melanoma skin cancer * Patient with clinically significant cardiovascular disease defined as: * Inadequately controlled hypertension (systolic \> 150 and/or diastolic \> 100 on antihypertensive medications); prior history of hypertensive crisis or hypertensive encephalopathy * Unstable angina within 6 months of enrollment * NYHA Grade II or greater congestive heart failure * Serious cardiac arrythmia requiring medication * Grade 2 or greater peripheral vascular disease; claudication within 6 months * History of myocardial infarction within 6 months * Previously diagnosed coagulopathy, disseminated intravascular coagulopathy, immune thrombocytopenia purpura, thrombotic thrombocytopenia purpura or tumor involving major vessels * Significant vascular disease: aortic aneurysm, aortic dissection * Active thromboembolic disease: pulmonary embolism, deep venous thrombosis * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study; anticipation of need for major surgical procedure during course of the study * Minor surgical procedure other than central venous access placement, within 7 days prior to day 1 of study * Patients with proteinuria - patients with urine protein of 1+ on dipstick or \>=30 mg/dl at baseline should undergo UPCR; patients with UPCR of \>=1.0 should be excluded * Patients who are pregnant or lactating * No prior investigational agent within 30 days or planned participation in an experimental drug study * Patients whose circumstances do not permit completion of study or required follow-up * Prior therapy with bevacizumab or topotecan. Prior platinum therapy allowed as part of initial treatment * History of abdominal fistula, GI perforation or intra-abdominal abscess within 6 months prior to study enrollment. * Known hypersensitivity to any component of bevacizumab
References
Publications (1)
- DERIVEDZighelboim I, Wright JD, Gao F, Case AS, Massad LS, Mutch DG, Powell MA, Thaker PH, Eisenhauer EL, Cohn DE, Valea FA, Alvarez Secord A, Lippmann LT, Dehdashti F, Rader JS. Multicenter phase II trial of topotecan, cisplatin and bevacizumab for recurrent or persistent cervical cancer. Gynecol Oncol. 2013 Jul;130(1):64-8. doi: 10.1016/j.ygyno.2013.04.009. Epub 2013 Apr 13. PMID 23591400