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Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas

Phase 1/Phase 2
10 Years
Not Enrolling

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Trial Information

Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas

Inclusion Criteria:

- All patients, 10 years of age or older with biopsy proven advanced soft tissue
sarcoma, who have failed at least one prior treatment for metastatic disease are
eligible if there is measurable or evaluable disease via RECIST.

- Patients must have a life expectancy of at least 12 weeks.

- Prior surgery or radiotherapy for primary tumor is acceptable but must be completed
at least 4 weeks from study entry, and patient should have completely recovered from
such procedures.

- Patients must have a Zubrod performance status of 0-2.

- Patients (or their legal guardian) must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of ≥ 1500 cells/mm3, hemoglobin > 8 g/dl, platelet count ≥ 100
000/mm3 and absence of a regular red blood cell transfusion requirement.

- Patients should have a normal hepatic function with a total bilirubin < the upper
limit of normal and SGOT or SGPT < 2 times the upper limit of normal, and adequate
renal function as defined by a serum creatinine ≤ 1.5 upper limit of normal.

- Fasting total cholesterol level < 350 mg/dL and triglyceride level < 400 mg/dL is

- Women of childbearing potential must have a negative pregnancy test.

- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and at least for 3 months.

Patients with brain metastases are eligible if they have been appropriately treated,are
asymptomatic and no longer require corticosteroids.

Exclusion Criteria

- Pregnant women or nursing mothers are not eligible.

- Patients must not receive any other concurrent chemotherapy or radiation during this

- Patients with severe medical illnesses such as uncontrolled diabetes, active
infections, or uncontrolled psychiatric illnesses are not eligible.

- Patients with known hypersensitivity to temsirolimus or sirolimus, receiving
concomitant antitumor therapy, or anticonvulsant therapy, or cardiac antiarrhythmic
drugs are not eligible.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) and toxicity profile of combination temsirolimus and irinotecan both administered intravenously on a weekly basis.

Outcome Time Frame:

2.5 years

Safety Issue:


Principal Investigator

Monte Shaheen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Institutional Review Board

Study ID:

INST 0909



Start Date:

October 2009

Completion Date:

November 2013

Related Keywords:

  • Sarcoma
  • INST 0909
  • Irinotecan
  • Temsirolimus
  • refractory sarcomas
  • 3066K1
  • 3066K1-1208
  • 20091334
  • Sarcoma



University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636