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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00523432
First received: August 29, 2007
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Genital Neoplasms, Female
Drug: Topotecan
Drug: CCI-779 (temsirolimus)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Tolerability of regimen [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: August 2007
Study Completion Date: December 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523432

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Gini Fleming, MD University of Chicago
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00523432     History of Changes
Other Study ID Numbers: 15424A
Study First Received: August 29, 2007
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
ovarian cancer
cervical cancer
uterine cancer
fallopian tube cancer
endometrial cancer
vaginal cancer
peritoneal cancer
reproductive cancer

Additional relevant MeSH terms:
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Everolimus
Sirolimus
Topotecan
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014