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

NCT00593060 | Completed Phase 1 DMC

• 1 other identifier: 07-172
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer; Colorectal Adenocarcinoma

Keywords

Temsirolimus; cetuximab; metastatic disease

Outcome Measures

Primary Outcomes (3)

• To determine the dose-limiting toxicities and maximal tolerated doses of cetuximab combined with temsirolimus.

  2 years

• To determine the dosing regimen appropriate for Phase 2 studies of the combination.

  2 years

• To determine the pharmacokinetics of combined treatment with cetuximab and temsirolimus.

  2 years

Secondary Outcomes (1)

• To document objective response rate and progression-free survival in patients treated with the combination.

  3 years

Study Arms (1)

Temsirolimus Combined With Cetuximab

EXPERIMENTAL

Drug: Temsirolimus; Drug: Cetuximab

Interventions

Temsirolimus DRUG

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.

Also known as: Torisel, CCI-779

Temsirolimus Combined With Cetuximab

Cetuximab DRUG

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.

Also known as: Erbitux

Temsirolimus Combined With Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeffrey W. Clark, MD: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

temsirolimus; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jeffrey W Clark, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: November 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2010
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

US (2)