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Trial record 1 of 1 for:    NCT01050985
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A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01050985
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Georgetown University

Tracking Information
First Submitted Date  ICMJE January 15, 2010
First Posted Date  ICMJE January 18, 2010
Last Update Posted Date February 13, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
  • 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 ]
  • To determine the response by radiology scans to temsirolimus and 5-FU-based therapies in patients with advanced malignancies [ Time Frame: 9 weeks ]
  • Comparison of the response rate in patients whose tumors demonstrate activation of the mTOR pathway versus those that do not [ Time Frame: 9 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer
Official Title  ICMJE A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies
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.

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  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 Advanced Solid Tumors
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: temsirolimus and capecitabine
Treatment with the combination of temsirolimus and capecitabine
Intervention: Drug: Temsirolimus and capecitabine
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2014)
47
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2010)
48
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT01050985
Other Study ID Numbers  ICMJE 2009-479
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Michael J Pishvaian, Md, PhD Georgetown University
PRS Account Georgetown University
Verification Date February 2014

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