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A Phase I Trial of Temsirolimus (CCI-779, Torisel) Combined With Cetuximab (Erbitux) in Cetuximab-Refractory Colorectal Cancer

Phase 1
18 Years
Not Enrolling
Colorectal Cancer, Colorectal Adenocarcinoma

Thank you

Trial Information

A Phase I Trial of Temsirolimus (CCI-779, Torisel) Combined With Cetuximab (Erbitux) in Cetuximab-Refractory Colorectal Cancer

- 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.

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

- 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

- History of hypersensitivity to polysorbate or cetuximab

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Eunice Kwak, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

October 2010

Related Keywords:

  • Colorectal Cancer
  • Colorectal Adenocarcinoma
  • Temsirolimus
  • cetuximab
  • metastatic disease
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617