Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix

Completed · Phase 2

Conditions studied: Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer

In brief

This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

Key facts

Study ID

NCT00025233

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2002-04-01

Expected to finish

2009-07-01

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed persistent or recurrent squamous cell carcinoma (SCC) of the cervix
• Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix
• Chemotherapy administered as a radio-sensitizer does not count as 1 regimen
• Documented disease progression
• At least 1 unidimensionally measurable lesion*
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• No tumor involving major blood vessels
• No history or physical evidence of CNS disease, including primary or metastatic brain tumor
• Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population
• Performance status - GOG 0-2 (if received 1 prior regimen)
• Performance status - GOG 0-1 (if received 2 prior regimens)
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No known bleeding disorder or coagulopathy
• No other active bleeding or pathologic condition that would confer a high risk of bleeding
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• INR ≤ 1.5 (or 2-3 for patients on a stable dose of therapeutic warfarin or low molecular weight heparin)
• PTT < 1.2 times control
• Creatinine ≤ 1.5 times ULN
• Creatinine clearance > 60 mL/min
• No proteinuria
• Urine protein < 1+ on dipstick or < 30 mg/dL
• Urine protein < 1000 mg by 24-hour urine collection

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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