Phase II Clinical Trial of Bevacizumab (NSC 704865) and Low Dose Oral Cyclophosphamide in Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

Trial ID # NCT00072566
Phase II
Drug Class Angiogenesis Inhibitors: VEGF
Drug Name Bevacizumab
Alternate Drug Names immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial Cyclophosphamide, Bevacizumab
Eligible Participant

Recurrent ovarian cancer with ≤3 prior therapies

Patients Enrolled

70, median 2 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DoR, PFS, evaluated per RECIST

Efficacy

ORR: 24% (17PR, n=70)
DCR: 87% (17PR, 44SD, n=70)
PFS: 7.2 months
OS: 16.9 months

Clinically Significant Adverse Events

Serious AE: three deaths, two pulmonary hypertension, one gastrointestinal perforation
Grade 3-4 AE: lymphopenia (20%), pain (19%), hypertension (16%)

Conclusion

Promising response rates of bevacizumab+cyclophosphamide combination

Reference

Garcia AA et al. Phase II Clinical Trial of Bevacizumab and Low-Dose Metronomic Oral Cyclophosphamide in Recurrent Ovarian Cancer: A Trial of the California, Chicago, and Princess Margaret Hospital Phase II Consortia. J Clin Oncol (2008) 26(1): 76-82
https://www.ncbi.nlm.nih.gov/pubmed/18165643

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