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

This study has been terminated.
(Original PI left institution and sponsor decided to end support.)
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00996346
First received: October 14, 2009
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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

To determine antitumor activity of this combination of drugs in refractory soft tissue sarcoma.


Condition Intervention Phase
Sarcoma
 Drug: irinotecan, temsirolimus
Drug: Temsirolimus and Irinotecan
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) and toxicity profile of combination temsirolimus and irinotecan both administered intravenously on a weekly basis. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: October 2009
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Level 1
Irinotecan at 80 mg/m2 weekly x3 Level 1: Temsirolimus 15 mg weekly x3
 Drug: irinotecan, temsirolimus
This is a single arm, non-randomized phase I/II trial of temsirolimus and irinotecan. Successive groups of 3 patients will be entered at escalating dose levels. Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest.
Other Name: INST 0909, irinotecan, temsirolimus,
Experimental: Arm 1 Level 2
Irinotecan at 80 mg/m2 weekly x3 Level 2: Temsirloimus 20 mg weekly x3
 Drug: irinotecan, temsirolimus
This is a single arm, non-randomized phase I/II trial of temsirolimus and irinotecan. Successive groups of 3 patients will be entered at escalating dose levels. Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest.
Other Name: INST 0909, irinotecan, temsirolimus,
Experimental: Arm 1 Level 3
Irinotecan at 80 mg/m2 weekly x3 Level 3 Temsirolimus 25 mg weekly x3
 Drug: irinotecan, temsirolimus
This is a single arm, non-randomized phase I/II trial of temsirolimus and irinotecan. Successive groups of 3 patients will be entered at escalating dose levels. Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest.
Other Name: INST 0909, irinotecan, temsirolimus,
Experimental: Arm 2 Level 1
Temsirolimus 25 mg weekly x3 Level 1 Irinotecan 50 mg/m2 weekly x3
 Drug: Temsirolimus and Irinotecan
Other Names:
  • Temsirolimus
  • Irinotecan
Experimental: Amr 2 Level 2
Temsirolimus 25 mg weekly x3 Level 2 Irinotecan 65 mg/m2 weekly x3
 Drug: Temsirolimus and Irinotecan
Other Names:
  • Temsirolimus
  • Irinotecan
Experimental: Arm 2 Level 3
Temsirolimus 25 mg weekly x3 Level 3 Irinotecan 80 mg/m2 weekly x3
 Drug: Temsirolimus and Irinotecan
Other Names:
  • Temsirolimus
  • Irinotecan

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 required.
  • 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 trial.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996346

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Monte Shaheen, MD University of New Mexico Cancer Center
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00996346     History of Changes
Other Study ID Numbers: INST 0909, 3066K1, 3066K1-1208, 20091334, NCI-2011-01940
Study First Received: October 14, 2009
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
INST 0909
Irinotecan
Temsirolimus
refractory sarcomas
 3066K1
3066K1-1208
20091334

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sirolimus
Everolimus
Irinotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
 Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013