A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies
NCT ID: NCT00523432
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2007-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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A
Arm A will consist of subjects without prior pelvic radiation or with radiation to a field smaller than the whole pelvis. Subjects will receive weekly CCI-779 and topotecan at the assigned dose.
Topotecan
Weekly doses via IV infusion. Dose will be assigned based on time of study entry.
CCI-779 (temsirolimus)
Weekly 25mg dose via IV infusion.
B
Arm A will consist of subjects with prior whole pelvic radiation. Subjects will receive weekly CCI-779 and topotecan at the assigned dose.
Topotecan
Weekly doses via IV infusion. Dose will be assigned based on time of study entry.
CCI-779 (temsirolimus)
Weekly 25mg dose via IV infusion.
Interventions
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Topotecan
Weekly doses via IV infusion. Dose will be assigned based on time of study entry.
CCI-779 (temsirolimus)
Weekly 25mg dose via IV infusion.
Eligibility Criteria
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Inclusion Criteria
* Prior Therapy: at least one and may have up to three prior cytotoxic chemotherapeutic regimens for the management of primary disease.
* Must be at least 18 years of age.
* GOG performance status must be 0 or 1.
* Patients must have adequate organ and marrow function as defined below:
* hemoglobin ≥10g/dL
* absolute neutrophil count ≥1,500/uL
* platelets ≥100,000/uL
* total bilirubin below the institutional upper limit of normal
* AST(SGOT)/ALT(SGPT) below the institutional upper limit of normal
* creatinine below the institutional upper limit of normal
* cholesterol ≤ 350 mg/dL (fasting)
* triglycerides ≤ 400 mg/dL (fasting)
* albumin ≥ 3.0 mg/dL
* negative pregnancy test for women able to have children
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* More than 3 prior cytotoxic chemotherapeutic regimens or treatment with temsirolimus or any other mTOR inhibitor
* Concomitant hormonal therapy or radiation therapy
* Clinically significant infections or other medical problems of significant severity
* History of unstable angina or myocardial infarction within the past six months
* Known brain metastases unless the metastases have been controlled by prior surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for at least 4 weeks.
* Any requirement for oxygen
* Cannot be receiving potent enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) nor any other potent CYP3A4 inducer such as rifampin or St. John's wort, as these may decrease temsirolimus levels. Use of agents that potently inhibit CYP3A4 (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited.
18 Years
FEMALE
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Gini Fleming, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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References
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Temkin SM, Yamada SD, Fleming GF. A phase I study of weekly temsirolimus and topotecan in the treatment of advanced and/or recurrent gynecologic malignancies. Gynecol Oncol. 2010 Jun;117(3):473-6. doi: 10.1016/j.ygyno.2010.02.022. Epub 2010 Mar 28.
Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
Other Identifiers
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15424A
Identifier Type: -
Identifier Source: org_study_id