Cervical Adenocarcinoma Clinical Trial
Official title:
A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients With Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix
This phase II trial studies the effects of temsirolimus in treating patients with cervical cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in cells that is part of one pathway that sends signals to stimulate cell growth and survival. By blocking this protein cancer cells may stop growing or die.
PRIMARY OBJECTIVES:
I. To assess the efficacy (objective response rate) of temsirolimus given intravenously (IV)
weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the
cervix.
II. To assess the adverse events, time to progression and response duration of temsirolimus
given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of
the cervix.
III. To explore the relationship between expression of proteins in the mammalian target of
rapamycin (mTOR) pathway in archival tissue samples from patients on this trial and their
objective response to therapy.
OUTLINE:
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete
responders, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity or for 2 courses after complete response criteria are first met. For
other patients, treatment repeats every 28 days for up to 12 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3
months (patients with complete response [CR], partial response [PR], or stable disease [SD]
only) thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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