A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Capecitabine; Everolimus; Sirolimus

Criteria

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