Phase I study of temsirolimus, capecitabine proves safe; positive survival trend seen

May 16, 2012

A phase I clinical trial examining the safety of combining temsirolimus and capecitabine in advanced malignancies suggests the two agents can be given safely to patients. In addition, the Georgetown Lombardi Comprehensive Cancer Center researchers conducting the study in cancer patients whose tumors have resisted multiple treatments say the combination demonstrates "promising evidence" of disease control and should be studied in a phase II trial. Their clinical findings and additional data from the study will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, June 1 through 5, 2012.

Temsirolimus is an mTOR inhibitor, meaning it stops mTOR from doing its job inside a cell. mTOR controls parts of a cell's machinery, including the production of proteins, and it is essential for . However, researchers know it's not enough to stop one in the vast majority of cancers. They hypothesize that by adding a chemotherapy, capecitabine, to temsirolimus, the combination will overwhelm the and cause them to die.

Thirty-two patients with advanced cancers volunteered to participate in the phase I study of temsirolimus and capecitabine. The men and women had received an average of four previous types of treatments. The study was designed to examine the safety of various combination doses among the patients. Side effects were assessed in 30 patients.

The most common adverse events were mucositis (inflammation and ulceration of the mucous membranes lining the digestive tract), and hypophosphatemia (low level of phosphorus in the blood causing bone pain, confusion and muscle weakness). The most common were fatigue (4), diarrhea (2) and hypophosphatemia (2). For 16 of 30 patients, the dose of was lowered to help alleviate side effects.

Of the 25 patients evaluable for the effectiveness of the combination, there were no partial responses or complete responses observed, but 14 patients had stable disease (no growth) – some with stable disease for more than six months. The median time to progression was three months with a median overall survival of seven months.

"We're not surprised by the safety profile of this combination," says the principal investigator, Michael Pishvaian, M.D., Ph.D., a gastrointestinal cancer specialist at Georgetown Lombardi. "While phase I studies are not designed to measure the tumor's response to a drug or combination of drugs, it is encouraging when we see some clinical benefit. Looking ahead, I anticipate this combination will be studied in phase II trial for colon cancer patients who have exhausted all options for treatments."

Explore further: New treatment regimen shows clinical benefit in advanced colon cancer

Related Stories

New treatment regimen shows clinical benefit in advanced colon cancer

May 18, 2011
A new treatment regimen for patients with metastatic colon cancer appears to offer clinical benefit even when used after multiple other treatments have failed, say research physicians at Georgetown Lombardi Comprehensive ...

New study finds two-drug combo slows advanced pancreatic cancer

April 3, 2012
The combination of the novel drug TH-302 with the standard drug gemcitabine has shown early signs of delaying the worsening of cancer in patients with advanced pancreatic cancer, a Mayo Clinic-led study has found. This was ...

Renal cancer drug temsirolimus shows promise against mesothelioma

May 1, 2011
A drug commonly used to treat kidney cancer may increase the effectiveness of chemotherapy for mesothelioma, according to a study published in the May issue of the Journal of Thoracic Oncology.

Recommended for you

Outdoor light at night linked with increased breast cancer risk in women

August 17, 2017
Women who live in areas with higher levels of outdoor light at night may be at higher risk for breast cancer than those living in areas with lower levels, according to a large long-term study from Harvard T.H. Chan School ...

Scientists develop novel immunotherapy technology for prostate cancer

August 17, 2017
A study led by scientists at The Wistar Institute describes a novel immunotherapeutic strategy for the treatment of cancer based on the use of synthetic DNA to directly encode protective antibodies against a cancer specific ...

Scientists develop blood test that spots tumor-derived DNA in people with early-stage cancers

August 16, 2017
In a bid to detect cancers early and in a noninvasive way, scientists at the Johns Hopkins Kimmel Cancer Center report they have developed a test that spots tiny amounts of cancer-specific DNA in blood and have used it to ...

Toxic formaldehyde is produced inside our own cells, scientists discover

August 16, 2017
New research has revealed that some of the toxin formaldehyde in our bodies does not come from our environment - it is a by-product of an essential reaction inside our own cells. This could provide new targets for developing ...

Cell cycle-blocking drugs can shrink tumors by enlisting immune system in attack on cancer

August 16, 2017
In the brief time that drugs known as CDK4/6 inhibitors have been approved for the treatment of metastatic breast cancer, doctors have made a startling observation: in certain patients, the drugs—designed to halt cancer ...

Researchers find 'switch' that turns on immune cells' tumor-killing ability

August 16, 2017
Molecular biologists led by Leonid Pobezinsky and his wife and research collaborator Elena Pobezinskaya at the University of Massachusetts Amherst have published results that for the first time show how a microRNA molecule ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.