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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

Phase 1
18 Years
Open (Enrolling)
Advanced/Recurrent Breast Cancer, Endometrial Cancer, Ovarian Cancer

Thank you

Trial Information

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

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.

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)

- Other concomitant anti-cancer therapy (except steroids)

- Concomitant use of streptozocin, mercaptopurine.

- Previous treatment with one of the study drugs.

- Previous treatment with other mTOR inhibitors

- Prior investigational therapy/agents within 4 weeks of start, in case of bevacizumab
at least 60 days between bevacizumab discontinuation and first dosing of

- Surgical treatment or radiation therapy in the past 4 weeks. Palliative radiotherapy
at focal sites on the extremities is allowed, also within 4 weeks before start

- Unresolved toxicity CTC ≥ grade 2 from previous anti-cancer therapy except alopecia.

- Known or suspected allergy to any investigational agent or any agent given in
association with this trial.

- Substance abuse, medical, psychological or social conditions that may interfere with
the patients participation in the study or evaluation of the study results

- Any condition that is unstable or which could jeopardize the safety of patient and
his compliance in the study.

- Antracyclines: > 450 mg/m2 doxorubicin or and > 600 mg/m2 epirubicin

- Medications known to have dysrhythmic potential is not permitted (ie, terfenadine,
quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol,
risperidone, indapamide)

- Usage of coumarin-derivate anticoagulants. Low molecular weight heparin is permitted
and advised

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD, pharmacokinetic parameters

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMCN st Radboud


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

June 2009

Completion Date:

August 2012

Related Keywords:

  • Advanced/Recurrent Breast Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • temsirolimus (Torisel®)
  • pegylated liposomal doxorubicin (PLD, Doxil®/ Caelyx®)
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Adenoma