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A Study of Combination of Temsirolimus (Torisel®) and Pegylated Liposomal Doxorubicin (PLD, Doxil®/Caelyx®) in Advanced or Recurrent Breast, Endometrial and Ovarian Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1

A Study of Combination of Temsirolimus (Torisel®) and Pegylated Liposomal Doxorubicin (PLD, Doxil®/Caelyx®) in Advanced or Recurrent Breast, Endometrial and Ovarian Cancer

A Phase Ib Study of Combination of Temsirolimus (Torisel®) and Pegylated Liposomal Doxorubicin (PLD, Doxil®/ Caelyx®) in Advanced or Recurrent Breast, Endometrial and Ovarian Cancer

NCT00982631•Radboud University Medical Center

View on ClinicalTrials.gov

Summary

A study to examine the combination of temsirolimus and Caelyx® (chemotherapeutic) in advanced or recurrent breast, endometrial and ovarian cancer.

Detailed Description

To assess the maximum tolerated dose (MTD) and recommended phase II dose of the combination of temsirolimus and Caelyx® in patients with advanced or therapy refractory breast cancer, endometrial cancer, or ovarian cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with proven advanced breast cancer, endometrial cancer or ovarian cancer, who are refractory to standard therapies or for whom no standard therapy exists.
•Age ≥ 18 years
•Patients who have an ECOG status of 0 or 1
•Patients who have a life expectancy of at least 12 weeks
•Negative pregnancy test for female patients of childbearing potential
•Signed informed consent

Exclusion Criteria

•Adequate bone marrow: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and haemoglobin ≥ 5.0 mmol/l
•Adequate renal function: GFR ≥ 60 ml/min
•Adequate liver function: ALT and AST \< 2.5 x ULN, total bilirubin ≤ 1x ULN
•Fasting level of total cholesterol of no more than 350 mg/dL (9.1 mmol/L) and triglyceride level of no more than 400 mg/L (4.5 mmol/L)
•Left ventricular ejection fraction (LVEF) \< 50%
•History of serious cardiac disease
•Active clinically serious bacterial, viral or fungal infections (\> grade 2).
•Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
•Clinically symptomatic brain or meningeal metastasis. Patients with seizure disorders requiring medication (such as steroids or antiepileptics). Concomitant treatment with strong CYP3A4 inductors (such as rifampicin, St. John´s Wort) or CYP3A4 inhibitors (such as ketoconazole, voriconazole, itraconazole, diltiazem, verapamil, erythromycin) within 2 weeks prior to start.
•Moderate or weak CYP3A4 modifiers should be used concomitantly only after careful assessment of risk-benefit ratio. Concomitant use of carbamazepine, phenobarbital, phenytoin or chronic use of dexamethasone is not allowed. (Table 1)
+13 more criteria

Locations (1)

University Medical Center Nijmegen st Radboud

Nijmegen, Gelderland, Netherlands

Key Dates

Start Date

June 1, 2009

Primary Completion Date

February 1, 2012

Completion Date

August 1, 2012

Last Updated

April 11, 2012

Enrollment

ESTIMATED participants

Conditions

Advanced/Recurrent Breast CancerEndometrial CancerOvarian Cancer

Interventions

Temsirolimus/PLD

DRUG

Contacts

C.M.L. van Herpen, Md, Phd

CONTACT

+31 24 3610353 c.vanherpen@onco.umcn.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Combination of Temsirolimus (Torisel®) and Pegylated Liposomal Doxorubicin (PLD, Doxil®/Caelyx®) in Advanced or Recurrent Breast, Endometrial and Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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