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

NCT00523432

Last updated date
Study Location
University of Chicago
Chicago, Illinois, 60637, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Female Genital Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Female Genital NeoplasmsA Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies
NCT00523432
  1. Chicago, Illinois
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Drug: Topotecan
    Weekly doses via IV infusion. Dose will be assigned based on time of study entry.
  • Drug: CCI-779 (temsirolimus)
    Weekly 25mg dose via IV infusion.
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Topotecan
    • Drug: CCI-779 (temsirolimus)
  • Experimental: B
    Arm A will consist of subjects with prior whole pelvic radiation. Subjects will receive weekly CCI-779 and topotecan at the assigned dose.
    Interventions:
    • Drug: Topotecan
    • Drug: CCI-779 (temsirolimus)
Publications *

*   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
 (submitted: April 25, 2011)
15
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2007)
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:

  • 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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
Principal Investigator:Gini Fleming, MDUniversity of Chicago
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