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Phase I Study of Pegylated Liposomal Doxorubicin and Temsirolimus in Resistant Solid Malignancies

Phase 1
18 Years
Not Enrolling
Resistant Solid Malignancies

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Trial Information

Phase I Study of Pegylated Liposomal Doxorubicin and Temsirolimus in Resistant Solid Malignancies

Inclusion Criteria

Inclusion and Exclusion Criteria:

- Patients must have a histologically or cytologically proven solid malignancy which is
resistant to conventional therapy or for which no effective therapy is known.

- Patients with measurable or non-measurable disease are eligible for entry to this
study. In addition, patients without measurable or non-measurable disease are also

- Patients must have recovered from the acute toxic effects of all prior chemotherapy,
immunotherapy, or radiotherapy prior to entering this study. No chemotherapy or
radiotherapy may be given within 4 weeks prior to the start of protocol treatment.

- Patients must be ≥18 years old.

- ECOG 0-2 at study entry.

- Patients must have a life expectancy of greater than 8 weeks.

- Required Laboratory Values:

- absolute neutrophil count ≥1,500/mm3

- platelets ≥100,000/mm3

- hemoglobin ≥9.0 g/dL

- total bilirubin ≤1.5 x ULN

- AST(SGOT)/ALT(SGPT) ≤1.5 x ULN (≤2.5 x ULN for patients with liver metastases)

- alkaline phosphatase ≤2.5 x ULN

- creatinine ≤1.5 x ULN OR

- creatinine clearance ≥60 mL/min/1.732 for patients with creatinine levels above 2.0

- serum cholesterol ≤350 mg/dL /9.0 mmol/L (fasting)

- triglycerides ≤400 mg/dL (fasting)*

- albumin ≥3.0 mg/dL

- PT/INR ≤1.5, unless the patient is on full dose warfarin or stable dose of LMW
heparin with a therapeutic INR of >1.5 - ≤3 *Patients with triglyceride levels >400
mg/dL can be started on lipid lowering agents and reevaluated within 1 week. If
levels go to ≤400 mg/dL, they can be considered for the trial and continue the lipid
lowering agents.

- Temsirolimus is primarily metabolized by CYP3A4. Patients cannot be receiving
enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine,
phenobarbital) nor any other CYP3A4 inducer such as rifampin or St. John's wort, as
these may decrease temsirolimus levels.

- Patients with known hypersensitivity reactions to macrolide antibiotics (such as
erythromycin, clarithromycin, and azithromycin) are not eligible for this trial.

- Patients must have a normal left ventricular ejection fraction (LVEF ≥50%) by MUGA

- For all sexually active patients, the use of adequate contraception (hormonal or
barrier method of birth control) will be required prior to study entry and for the
duration of study participation. Non-pregnant status will be determined in all women
of childbearing potential. Pregnant and nursing women are not eligible.

- Patients receiving anti-retroviral therapy (HAART) for HIV infection are excluded
from the study because of possible pharmacokinetic interactions.

- Patients must not have active CNS disease.

- Patients must have recovered from uncontrolled intercurrent illness including, but
not limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris or cardiac arrhythmia.

- Patients must have signed a Washington University, Human Research Protection Office
(HRPO) approved informed consent. The patient should not have any serious medical or
psychiatric illness that would prevent either the giving of informed consent or the
receipt of treatment.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of temsirolimus in combination with pegylated liposomal doxorubicin in patients with resistant solid malignancies.

Outcome Time Frame:

After completion of cycle 1 by all patients

Safety Issue:


Principal Investigator

Joel Picus, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

July 2011

Related Keywords:

  • Resistant Solid Malignancies
  • Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110