CIRCCa - A Randomized Double Blind Phase II Trial of Carboplatin-Paclitaxel Plus Cediranib Versus Carboplatin-Paclitaxel Plus Placebo in Metastatic/Recurrent Cervical Cancer
OBJECTIVES:
Primary
- To provide preliminary evidence regarding whether the addition of cediranib maleate to
a combination of carboplatin and paclitaxel will increase the progression-free survival
by 50% from 4 to 6 months in patients with metastatic or recurrent, undetectable
cervical carcinoma.
Secondary
- To provide estimates of differences in response, survival, toxicity, quality of life,
and pharmacodynamic end-points between the study arms.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3
hours on day 1. Patients also receive oral placebo once daily.
- Arm II: Patients receive carboplatin and paclitaxel therapy as in Arm I. Patients also
receive oral cediranib maleate once daily.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Patients with complete response, partial response, or
stable disease following completion of therapy receive cediranib maleate or placebo until
evidence of progression or toxicity.
Blood samples may be collected periodically for evaluation of the VEGFR signaling inhibitor
cediranib maleate and identification of suitable biomarkers that predict cediranib maleate
response. Quality-of-life is assessed by the EORTC QLQ-C30 and QLQ-CX24 cervix subscale
questionnaires at baseline and periodically during study and follow up.
After completion of study therapy, patients are followed up every 2 months for 3 years,
every 6 months for 2 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Overall progression-free survival
No
R. Paul Symonds, MD, FRCP, FRCR
Principal Investigator
University Hospitals, Leicester
Unspecified
CDR0000687338
NCT01229930
June 2010
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