NCT01050985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

2.7 years

First QC Date

January 15, 2010

Last Update Submit

February 12, 2014

Conditions

Advanced Solid Tumors

Keywords

advanced cancertemsirolimuscapecitabine

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (3)

  • Evaluation of toxicity of the combination of temsirolimus plus capecitabine in patients with advanced malignancies as determined by adverse events observed and lab values

    1 year

  • To determine the response by radiology scans to temsirolimus and 5-FU-based therapies in patients with advanced malignancies

    9 weeks

  • Comparison of the response rate in patients whose tumors demonstrate activation of the mTOR pathway versus those that do not

    9 weeks

Study Arms (1)

temsirolimus and capecitabine

EXPERIMENTAL

Treatment with the combination of temsirolimus and capecitabine

Drug: Temsirolimus and capecitabine

Interventions

Temsirolimus and capecitabineDRUG

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

Also known as: Temsirolimus, Torisel, CC-779, NSC 022088, Capecitabine, Xeloda
temsirolimus and capecitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center

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

Location

MeSH Terms

Interventions

temsirolimusCapecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Michael J Pishvaian, Md, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

US(1)