A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050985
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : February 13, 2014
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Georgetown University

Brief Summary:

This study is for people with advanced cancer for which no curative treatment exists.

The purpose of this study is to test the safety and effectiveness of the combination of the drugs Temsirolimus and Capecitabine and see what effects it has on cancer.

Temsirolimus is a drug that is given by vein that targets a protein important for the growth of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer cell growth and even lead to their death.

Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in the body to the very common chemotherapy known as 5-fluorouracil.

This research is being done because it is not known if the combination of Temsirolimus and Capecitabine will work better than Capecitabine or Temsirolimus alone.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Temsirolimus and capecitabine Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies
Study Start Date : July 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: temsirolimus and capecitabine
Treatment with the combination of temsirolimus and capecitabine
Drug: Temsirolimus and capecitabine
temsirolimus in escalating doses starting at 15-mg IV on days 1 and 8 of a 14 day cycle capecitabine in escalating doses starting at 1000 mg/m2 by mouth twice a day on days 1-7 of a 14-day cycle
Other Names:
  • Temsirolimus
  • Torisel
  • CC-779
  • NSC 022088
  • Capecitabine
  • Xeloda

Primary Outcome Measures :
  1. Identification of the recommended Phase II dose of temsirolimus to be used in combination with capecitabine in patients with advanced malignancies [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evaluation of toxicity of the combination of temsirolimus plus capecitabine in patients with advanced malignancies as determined by adverse events observed and lab values [ Time Frame: 1 year ]
  2. To determine the response by radiology scans to temsirolimus and 5-FU-based therapies in patients with advanced malignancies [ Time Frame: 9 weeks ]
  3. Comparison of the response rate in patients whose tumors demonstrate activation of the mTOR pathway versus those that do not [ Time Frame: 9 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 therapy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050985

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20057
Sponsors and Collaborators
Georgetown University
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Michael J Pishvaian, Md, PhD Georgetown University

Responsible Party: Georgetown University Identifier: NCT01050985     History of Changes
Other Study ID Numbers: 2009-479
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Georgetown University:
advanced cancer

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents