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

NCT00996346

Last updated date
Study Location
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sarcoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 per Response Evaluation Criteria In Solid Tumors (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 Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas
Official Title  ICMJE Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas
Brief Summary

Refractory soft tissue sarcoma remains a difficult malignancy to treat. The mammalian target of rapamycin (mTOR) is an enzyme that plays an important role in cancer cell survival. mTOR inhibitors, like temsirolimus, have shown activity in sarcoma. Irinotecan is a chemotherapy drug that has also been used to treat sarcoma. However, it is unknown whether combining these two drugs would result in improved efficacy with acceptable toxicity.

Therefore, the goal of this phase I study is to determine the maximum tolerated dose (MTD) and toxicity profile of combination temsirolimus and irinotecan both administered intravenously on a weekly basis to refractory soft tissue sarcoma patients.

Detailed Description

Mammalian target of rapamycin (mTOR) inhibitors are anti-neoplastic agents with a wide potential range of clinical applications. The topoisomerase I inhibitor irinotecan is a potent DNA damaging drug. mTOR appears to enhance cancer cell survival following DNA damage, so it's reasonable to expect that mTOR inhibition combined with irinotecan may result in synergistic activity.

This is a single arm, non-randomized phase I trial of temsirolimus (an mTOR inhibitor) and irinotecan (a topoisomerase I inhibitor) in refractory soft tissue sarcoma patients. Successive groups of three patients will be entered at escalating dose levels. Irinotecan and temsirolimus will be administered weekly for three weeks followed by one week of rest. One course will therefore be four weeks. No intra-patient dose escalation will be allowed. Each patient will be treated until disease progression or intolerable side effects develop. Dose limiting toxicities will be assessed and the maximum tolerated dose will be reported.

Note that this trial was originally designed as a phase I/II study, but only the phase I portion was completed and will be reported.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE
  • Drug: Irinotecan&Temsirolimus:Arm1, Level 1
    Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.
    Other Names:
    • Irinotecan = Camptosar, Campto, or CPT-11
    • Temsirolimus = Toricel or CCI-779
  • Drug: Irinotecan&Temsirolimus:Arm 1, Level 2
    Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.
    Other Names:
    • Irinotecan = Camptosar, Campto, or CPT-11
    • Temsirolimus = Toricel or CCI-779
  • Drug: Irinotecan&Temsirolimus:Arm 2, Level 1
    Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.
    Other Names:
    • Irinotecan = Camptosar, Campto, or CPT-11
    • Temsirolimus = Toricel or CCI-779
Study Arms  ICMJE
  • Experimental: Irinotecan&Temsirolimus:Arm 1, Level 1

    Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.

    One cycle is four weeks.

    Intervention: Drug: Irinotecan&Temsirolimus:Arm1, Level 1
  • Experimental: Irinotecan&Temsirolimus:Arm 1, Level 2

    Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.

    One cycle is four weeks.

    Intervention: Drug: Irinotecan&Temsirolimus:Arm 1, Level 2
  • Experimental: Irinotecan&Temsirolimus:Arm 2, Level 1

    Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.

    One cycle is four weeks.

    Intervention: Drug: Irinotecan&Temsirolimus:Arm 2, Level 1
Publications * Verschraegen CF, Movva S, Ji Y, Schmit B, Quinn RH, Liem B, Bocklage T, Shaheen M. A phase I study of the combination of temsirolimus with irinotecan for metastatic sarcoma. Cancers (Basel). 2013 Apr 11;5(2):418-29. doi: 10.3390/cancers5020418.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 19, 2012)
17
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2009)
30
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 per Response Evaluation Criteria In Solid Tumors (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 Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00996346
Other Study ID Numbers  ICMJE INST 0909
3066K1 ( Other Identifier: Wyeth )
3066K1-1208 ( Other Identifier: Wyeth )
20091334 ( Other Identifier: Western IRB )
NCI-2011-01940 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New Mexico Cancer Care Alliance
Study Sponsor  ICMJE New Mexico Cancer Care Alliance
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Monte Shaheen, MDUniversity of New Mexico Cancer Center
PRS Account New Mexico Cancer Care Alliance
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP