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Temsirolimus (CCI-770, Torisel) Combined With Cetuximab in Cetuximab-Refractory Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00593060
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : December 2, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this study, the investigational drug, temsirolimus, will be combined with cetuximab, a biologic agent used in the treatment of colorectal cancer. Cetuximab in combination with temsirolimus may be more effective in treating advanced colorectal cancer than cetuximab alone. The purpose of this research study is to try to define the highest dose of cetuximab that can be used safely in combination with temsirolimus to treat advanced colorectal cancer that has progressed through standard therapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Adenocarcinoma Drug: Temsirolimus Drug: Cetuximab Phase 1

Detailed Description:
  • Because this is a study to determine the highest dose of cetuximab that can be safely given with temsirolimus, groups of 3 participants will be treated at gradually increasing doses of cetuximab. Each group of 3 participants must complete 4 weeks (1 cycle) of treatment before the following group of 3 participants can start treatment at the higher dose.
  • Cetuximab is administered intravenously 7 days before the treatment cycle begins. Participants will receive a cetuximab infusion every week of the treatment cycle (days 1, 8, 15, 22) along with temsirolimus. Temsirolimus is also given intravenously.
  • As a precaution, participants will be pre-medicated with Benadryl/diphenhydramine to help prevent an allergic reaction.
  • During the study participants will have weekly clinical visits. Each clinic visit will last approximately 2-3 hours. During the clinic visit, the following tests and procedures will be performed: Physical exam; vital signs; and blood tests. A CT scan will be performed after every 2 cycles (8 weeks).
  • Pharmacokinetic (PK) blood samples will be taken at various points during the study. For each PK sample, we will take about 1 teaspoon of blood. There will be a total of 22 tubes of blood taken for the PK study.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Temsirolimus (CCI-779, Torisel) Combined With Cetuximab (Erbitux) in Cetuximab-Refractory Colorectal Cancer
Study Start Date : October 2007
Primary Completion Date : October 2009
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Temsirolimus
    Given intravenously every week of each 28-day cycle (days 1, 7, 15, 22). Participants can continue to receive study treatment as long at their tumor is responding.
    Drug: Cetuximab
    One dose is given intravenously 7 days prior to the start of each 28-day cycle, then it is given every week (along with temsirolimus)of each 28-day cycle (on days 1, 7, 15, 22). Participants can continue to receive study treatment as long at their tumor is responding.

Outcome Measures

Primary Outcome Measures :
  1. To determine the dose-limiting toxicities and maximal tolerated doses of cetuximab combined with temsirolimus. [ Time Frame: 2 years ]
  2. To determine the dosing regimen appropriate for Phase 2 studies of the combination. [ Time Frame: 2 years ]
  3. To determine the pharmacokinetics of combined treatment with cetuximab and temsirolimus. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To document objective response rate and progression-free survival in patients treated with the combination. [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously treated metastatic colorectal adenocarcinoma, histologically proven. Subjects must have previously received and had evidence of progression on cetuximab, bevacizumab, 5FU, irinotecan, and oxaliplatin, or demonstrated intolerance to those agents (except cetuximab).
  • Measurable disease by RECIST criteria
  • ECOG Performance Status 0 or 1.
  • Male or female, 18 years of age or older.
  • Life expectancy greater than or equal to 12 weeks.
  • At least 2 weeks have elapsed between previous anti-cancer therapy AND resolution of any skin rash related to prior treatment with an epidermal growth factor receptor inhibitor.
  • Lab values within ranges as outlined in protocol

Exclusion Criteria:

  • Diagnosis of second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=2, atrial fibrillation, QTc prolongation to >450msec for males and >470 msec for females.
  • Known immunodeficiency disorders or active infections requiring treatment
  • Pregnancy or breastfeeding
  • Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
  • Prior radiation therapy or major surgery within 2 weeks of study entry
  • Prior radiation therapy to > 25% of the bone marrow
  • Treatment with other experimental or alternative therapies during the course of the trial
  • History of hypersensitivity to polysorbate or cetuximab
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593060

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Eunice Kwak, MD, PhD Massachusetts General Hospital
More Information

Responsible Party: Eunice L. Kwak, MD, PhD, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00593060     History of Changes
Other Study ID Numbers: 07-172
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: December 2011

Keywords provided by Eunice L. Kwak, MD, PhD, Massachusetts General Hospital:
metastatic disease

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents