A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies
NCT00523432
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- Histologically confirmed recurrent or metastatic ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma, cervical carcinoma, endometrial carcinoma, vulvar carcinoma, vaginal carcinoma, or carcinosarcoma of the ovary, endometrium or cervix.
- 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.
- Prior therapy with topotecan
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies | |||
Official Title ICMJE | A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies | |||
Brief Summary | The aim of the trial is to determine the recommended phase II dose of weekly intravenous topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous temsirolimus in patients with and without prior pelvic radiation. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Genital Neoplasms, Female | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 15 | |||
Original Estimated Enrollment ICMJE | 24 | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00523432 | |||
Other Study ID Numbers ICMJE | 15424A | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Chicago | |||
Study Sponsor ICMJE | University of Chicago | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Chicago | |||
Verification Date | September 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |