Know Cancer

forgot password

Phase II Trial of Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer

Phase 2
18 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

Phase II Trial of Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer

Cervical cancer remains a major cause of morbidity and mortality in women. Chemoradiation
has led to improvements in survival, but the prognosis for patients with recurrent,
metastatic cervical cancer remains poor. There is the need for more effective treatments for
the management of recurrent/persistent cervical cancer. Angiogenesis appears to play an
important role in cervical cancer development and progression, therefore VEGF inhibition
appears to be a rationale therapeutic strategy for cervical cancer. There is increasing
evidence that combining an anti-angiogenic agent with either cytotoxic chemotherapy or
radiation enhances anti-tumor activity. This study combines the current most active
chemotheraputic regimen for cervical cancer (cisplatin + topotecan) with an anti-angiogenic

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine anti-tumor activity as measured by surviving progression-free

Outcome Time Frame:

Progression-free survival for at least 6 months

Safety Issue:


Principal Investigator

David G Mutch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

December 2012

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms



Washington University School of Medicine - Division of Gyn Oncology St. Louis, Missouri  63110