A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer

NCT ID: NCT01050985

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-06-30

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

temsirolimus and capecitabine

Treatment with the combination of temsirolimus and capecitabine

Group Type: EXPERIMENTAL

Temsirolimus and capecitabine

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Temsirolimus; Torisel; CC-779; NSC 022088; Capecitabine; Xeloda

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Pishvaian, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Medical Center

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

Countries

United States

Other Identifiers

2009-479

Identifier Type: -

Identifier Source: org_study_id