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NCT Number: NCT01050985

A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temsirolimus and capecitabine

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2010
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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