Clinical trial tests targeting prostate cancer treatment


Are certain drugs more effective against some types of prostate cancers than others? Researchers know that not all therapies work for all patients – the next question is to figure out how to match the right treatments with the right patients.

A new clinical trial is testing whether an experimental drug can maximize the effect of current treatment and whether matching that drug to a genetic anomaly can lead to better, more personalized treatment for prostate cancer. The trial, led by investigators at the University of Michigan Comprehensive Cancer Center, is being conducted at 11 sites throughout the country. Continue reading

Your invitation to Ann Arbor’s Breast Cancer Summit

A community event

If you are a breast cancer survivor, caregiver or member of the general public concerned about breast cancer, please join us for a Breast Cancer Summit on Saturday, April 20, at Washtenaw Community College. The summit bridges the gap between our community and academic medicine by giving the audience a chance to ask questions and interact with U-M breast cancer specialists. Many are leaders nationally in the fight against breast cancer.

Maria Lyzen, right, and Ruth Freedman lead the Cancer Center's Breast Cancer Advisory and Advocacy Committee.

Maria Lyzen, right, and Ruth Freedman lead the Cancer Center’s Breast Cancer Advisory and Advocacy Committee.

The summit was organized through encouragement from the U-M Comprehensive Cancer Center’s breast cancer advocates. They feel the summit is a way to let the community know that the U-M breast cancer specialists are collaborative and multidisciplinary. Panel discussions and a mock tumor board will give the audience a first-hand look at how these leading oncologists work together on behalf of their patients. They will also give an update on the latest breast cancer research at Michigan and nationally, showing what has been learned and how vital research donations are to these research advances.

The summit will cover:

  • cancer prevention
  • screening
  • treatment
  • research, including clinical trials
  • survivorship
  • genetic risk Continue reading

Screening for Colorectal Cancer: Time to Stop Avoiding the Colonoscopy

“Your doctor said you need WHAT?” People can feel a bit uneasy when a doctor mentions screening for colon cancer or rectal cancer.

Danielle Turgeon, M.D., is one of the University of Michigan gastroenterologists who perform colonoscopies.

Danielle Turgeon, M.D., is one of the University of Michigan gastroenterologists who perform colonoscopies.

But, according to the American Cancer Society, colorectal cancer is the third most common cancer in both men and women in the United States. Preventing colorectal cancer, and not just finding it early, is why doctors recommend colorectal screening tests, even though the subject may seem embarrassing to discuss.

Colorectal cancer starts in the colon or rectum, most often as a polyp, or small piece of tissue that projects from the inner wall. Screening tools can find cancer in people before symptoms show up, which is when colorectal cancer is most easily treatable. Some also can find and remove suspicious-looking polyps before they become cancerous, which may prevent colorectal cancer.

Who should be screened:

  • Starting at age 50, men and women of average risk for colorectal cancer
  • People with a personal or family history of colorectal cancer or pre-cancerous polyps
  • People with inflammatory bowel disease
  • People with certain other risk factors, including a known family history of a hereditary colorectal cancer syndrome

The American Cancer Society recommends the following screening tests: Continue reading

New Clinical Trial for Thyroid Cancer Patients

Many types of tumors can start in the thyroid gland, which is in the front of the neck, below the Adam’s apple. Most of them are benign (non-cancerous) but others are malignant (cancerous), which means they can spread into nearby tissues and to other parts of the body. The two most common types of cancer are papillary carcinoma and follicular carcinoma. There are other types of thyroid cancer, which are rare.

Thyroid cancer is commonly diagnosed at a younger age than most other adult cancers. Nearly two out of three cases are found in people younger than 55 years of age. About 2% of thyroid cancers occur in children and teens.

Ronald J. Koenig, M.D.

Ronald J. Koenig, M.D.

Most thyroid cancers can be cured by surgery and radioactive iodine. However, thyroid cancers not cured by those therapies present a problem. As a rule, thyroid cancers do not respond well to chemo. But unlike standard chemo drugs, targeted drugs attack certain targets on cancer cells. The targets they attack can be present on normal cells as well, but the goal is to find targets that help cancer cells grow and thrive.

Ronald Koenig, M.D., Ph.D., professor of internal medicine at U-M, heads a research team focused on developing targeted drug therapies for thyroid cancer. He talked with mCancer Partner about a new clinical trial that is opening enrollment for certain patients with thyroid cancer.


mCancer Partner: Can you tell me about your newest clinical trial?

Dr. Koenig: In this new trial, to be funded by the National Cancer Institute, we are investigating whether a drug, Actos (pioglitazone), is useful in treating a certain kind of thyroid cancer. Actos is approved by the FDA to treat diabetes, but has not been approved yet to treat any cancers.

mCancer Partner: Who can enroll in this clinical trial?

Dr. Koenig: We will enroll adults with a history of follicular thyroid carcinoma or follicular variant of papillary thyroid carcinoma. These people must have metastatic disease or disease that has recurred locally in the neck, and that cannot be cured by further surgery or radioiodine. We will treat them for at least 24 weeks with daily pioglitazone and measure for response using CT scans and blood tests.

mCancer Partner: Where can someone learn more about this clinical trial?

Dr. Koenig: Details, along with contact information for enrolling, are available through UMClinicalStudies. This is a helpful website allowing people to easily search and find clinical and health research studies happening at the U-M. Our study’s ClinicalTrials.gov Identifier is NCT01655719.

Learn more about the Cancer Center’s thyroid cancer program or call the U-M Cancer AnswerLine at 800-865-1125 to speak with a nurse.

Why is Pancreatic Cancer so Challenging?

The pancreas is located deep inside the body, so early tumors cannot be seen or felt by health care providers during routine physical exams. This makes it hard to see the pancreas with imaging technologies and sometimes makes it difficult to access to remove cells for a biopsy.

Pancreatic cancer is a relatively rare cancer and it typically affects people older than age 50. Pancreatic cancer is hard to diagnose because the early symptoms are usually vague. Early symptoms may be nothing more than a general feeling of discomfort in the abdomen or an unexplained weight loss.

Another factor that makes pancreatic cancer so deadly is its resistance to treatment. At this time, the only possibility for long-term survival is surgically removing the cancer. Researchers are working on ways to detect the disease earlier, because that might allow more people to be eligible for surgery.

What tests are used to diagnose pancreatic cancer?

  • History and physical exam
  • Computed tomography (CT, CAT) scan
  • Magnetic resonance imaging (MRI)
  • Somatostatin receptor scintigraphy(OctreoScan) – helpful in diagnosing pancreatic neuroendocrine tumors
  • Positron emission tomography (PET) scan
  • Ultrasonography (ultrasound)
  • Endoscopic retrograde cholangiopancreatography (ERCP)
  • Angiography
  • Blood tests- Elevated blood levels of the tumor markers CA 19-9 and carcinoembryonic antigen (CEA) may point to a diagnosis of  pancreatic cancer made of exocrine cells, but these tests aren’t always accurate
  • Biopsy – A patient’s history, physical exam, and imaging test results may strongly suggest pancreatic cancer, but the only way to be sure is to remove a small sample of tumor and look at it under the microscope. This procedure is called a biopsy.

When disease has advanced beyond surgery’s reach, chemotherapy is the standard treatment. Two drugs are FDA-approved for the treatment of pancreatic cancer: gemcitabine (Gemzar) and erlotinib (Tarceva).

Research focusing on pancreatic cancer is increasing. Researchers are investigating ways to more effectively screen for the disease and examining possibilities for better treatment options.

U-M is involved in pancreatic cancer research; if you would like to learn more about our research and clinical trials, the following resources are available:

UMCC 2010.003 Cancer Stem Cells and Inhibition of Hedgehog Pathway Signaling in Advanced Pancreas Cancer: A Pilot Study of GDC-0449 in Combination With Gemcitabine

U-M Success Stories

What it Takes for New Drugs to be Tested and Reach Patients

What goes into researching and developing a cancer drug and what is required for approval by the Food and Drug Administration (FDA)? We sat down with Moshe Talpaz, M.D., Associate Director of translational research at the U-M Comprehensive Cancer Center, for a closer look at the FDA approval process.

Moshe Talpaz, M.D., has been involved in the FDA approval process of many cancer drugs. He leads translational research at the U-M Comprehensive Cancer Center.

Q: What is the general timeframe for a new drug to be approved by the FDA so it is available to patients?

From beginning to end, typical clinical drug development takes around 7-10 years. If a drug is showing remarkable activity and serves an unmet medical need, an accelerated process can go much quicker, maybe around 3 years after the onset of clinical trials.

Q: What is the first part of the process in developing a new drug?

The preclinical process is quite elaborate. Academic medical centers like U-M have the role of discovering what governs a disease, to discover the mutation that drives an illness like cancer. We first focus on the biology to show the full sequence of events in the body. We develop various laboratory approaches to demonstrate that shutting off the abnormal protein kills the cancer cell.

Drug companies then get involved. Medicinal chemists study many different molecules to identify one that has the characteristics of potentially becoming a drug.  This becomes the subject for extensive testing on animals to determine that it works safely in the body.

Q: When does research begin with actual patients?

Phase I testing in humans aims to find the maximum tolerated dose. We start with very low doses to check for toxicity. We end up with a safe dose to recommend for use in a Phase II study.

Phase II involves more extensive testing and is where we demonstrate whether the compound is effective and which tumors respond to it.

Phase III is a randomized study of large groups of patients that compares the potential drug to the current standard of care. If the compound reaches a significant goal, which is acceptable to the FDA, the FDA approves it.

Q: What about drugs that go through the accelerated process for FDA approval? Are there disadvantages when drugs go through the process quickly?

I believe the FDA approval process is streamlined and efficient. If a compound proves to be good and there is no question about it, it moves forward quickly in the approval process.

The FDA requires further testing on the drug once patients are using it, and the drug must meet additional milestones later.

Learn more about the clinical trials at the U-M Comprehensive Cancer Center.