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A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies

This is a Phase I study designed to assess the safety and clinical activity of temsirolimus
in combination with capecitabine in patients with advanced malignancies. Because the
toxicities of capecitabine are well established, and based on a previous clinical trial of
temsirolimus and continuous infusion 5-fluorouracil, an alternating dose escalation plan
will be employed.

The first stage of the study will be performed to identify the maximally tolerated dose of
the combination, when capecitabine is given on a every 2 week schedule. The starting dose of
temsirolimus will be 15-mg IV on day 1 and 8 plus capecitabine 1000 mg/m2 by mouth twice a
day on days 1-7 of a 14 day schedule. Patients will be enrolled in a standard 3+3 dose
escalating fashion to a maximum dose of temsirolimus of 25-mg and a maximum dose of
capecitabine of 1750 mg/m2 twice a day.

If the maximally tolerated dose is determined for the every 2 week schedule, then in the
second stage of the study a similar dose escalation plan will be employed for an every 3
week schedule.

Inclusion Criteria:

- Histologically proven adenocarcinoma with measurable or evaluable disease

- Disease for which capecitabine is approved or compendia listed

- Advanced unresectable, and/or metastatic disease for which there is no known curative

- Performance status 0-2

- Adequate hepatic, bone marrow, and renal function

Exclusion Criteria:

- Brain metastases not under control for at least 3 months

- Active severe infection or known chronic infection with HIV, hepatitis B virus, or
hepatitis C virus

- Cardiovascular disease problems including unstable angina, therapy for
life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or
congestive heart failure within the last 6 months

- Life-threatening visceral disease or other severe concurrent disease

- Women who are pregnant or breastfeeding

- Anticipated patient survival under 3 months

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:

Identification of the recommended Phase II dose of temsirolimus to be used in combination with capecitabine in patients with advanced malignancies

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Michael J Pishvaian, Md, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

June 2013

Related Keywords:

  • Advanced Solid Tumors
  • advanced cancer
  • temsirolimus
  • capecitabine



Georgetown University Medical Center Washington, District of Columbia  20007