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A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies

Phase 1
18 Years
Not Enrolling
Genital Neoplasms, Female

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Trial Information

A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability of regimen

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Gini Fleming, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

December 2010

Related Keywords:

  • Genital Neoplasms, Female
  • ovarian cancer
  • cervical cancer
  • uterine cancer
  • fallopian tube cancer
  • endometrial cancer
  • vaginal cancer
  • peritoneal cancer
  • reproductive cancer
  • Neoplasms
  • Genital Neoplasms, Female



University of ChicagoChicago, Illinois  60637