A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma
I. Determine the response rate, time to progression, and survival of patients with recurrent
advanced ovarian epithelial or primary peritoneal cavity cancer treated with gemcitabine
hydrochloride and 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).
II. Determine the toxicity of this regimen in these patients. III. Correlate the effect of
17-AAG alone on chaperone and client proteins in tumor samples and peripheral blood
mononuclear cells with response, time to progression, and survival of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to gemcitabine
hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine
hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine
hydrochloride as a single agent with disease progression while on treatment). Patients
receive tanespimycin intravenously (IV) over 2 hours on days 1 and 8 during course 1 and
days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on
day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity. Patients are followed
every 3 months until disease progression and then every 6 months for up to 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who experience a confirmed response according to modified RECIST criteria
Estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients, and binomial confidence intervals for 2-stage designs calculated according to the approach of Duffy and Santner. 95% confidence interval will be calculated.
Every 6 weeks
United States: Food and Drug Administration
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