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

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 I

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Topotecan hydrochloride Topotecan CCI 779

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety Study

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

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Tolerability of regimen [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.
B: Experimental 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 ≥ 3.5 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

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

Locations


United States, Illinois
	University of Chicago	Recruiting
	Chicago, Illinois, United States, 60637
	Contact: Takisha Wade, RN 773-834-1681

Sponsors and Collaborators

University of Chicago

Wyeth

Investigators


Principal Investigator:	Sarah Temkin, MD	University of Chicago

More Information

Responsible Party:	University of Chicago ( Sarah Temkin, MD )
Study ID Numbers:	UCIRB 15424A
First Received:	August 29, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00523432
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

Study placed in the following topic categories:

Uterine Cervical Neoplasms

Ovarian cancer

Vaginal Neoplasms

Ovarian Neoplasms

Genital Neoplasms, Female

Vaginal cancer

Uterine Neoplasms

Urogenital Neoplasms

Endometrial cancer

Fallopian tube cancer

Topotecan

Fallopian Tube Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	University of Chicago Wyeth
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00523432