A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01050985
First received: January 15, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: Temsirolimus and capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To determine the response by radiology scans to temsirolimus and 5-FU-based therapies in patients with advanced malignancies [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Comparison of the response rate in patients whose tumors demonstrate activation of the mTOR pathway versus those that do not [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: July 2010
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: temsirolimus and capecitabine
Treatment with the combination of temsirolimus and capecitabine
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050985

Locations
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20057
Sponsors and Collaborators
Georgetown University
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Michael J Pishvaian, Md, PhD Georgetown University
  More Information

No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01050985     History of Changes
Other Study ID Numbers: 2009-479
Study First Received: January 15, 2010
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
advanced cancer
temsirolimus
capecitabine

Additional relevant MeSH terms:
Sirolimus
Everolimus
Fluorouracil
Capecitabine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014