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Web Exclusive: Find a Clinical Trial That's Right for You
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Web Exclusive: Find a Clinical Trial That's Right for You
July 09, 2009
Web Exclusive: A Q&A with an Extraordinary Healer
June 30, 2009 – Kathy LaTour
Web Exclusive: Types of Kidney Cancer
June 25, 2009 – The American Cancer Society
Web Exclusive: Helpful Advice
June 25, 2009 – Elizabeth Whittington
Web Exclusive: Developing a Strategy
June 25, 2009 – Elizabeth Whittington
Web Exclusive: Searching for New Targets
June 23, 2009 – Elizabeth Whittington
Web Exclusive: When Survivors Should Exercise Caution
June 22, 2009 – Lena Huang
Web Exclusive: Fertility Guidelines Not Meeting Needs of Patients
June 22, 2009 – Elizabeth Whittington
Web Exclusive: A Peaceful Spirit
June 18, 2009 – Toby Bressler, RN, BSN, OCN
Web Exclusive: The Voice on the Other End of the Phone
June 18, 2009 – Dianne Ericson
Excerpt: Stronger
June 17, 2009 – Natalie Flechsig
Web Exclusive: An Infection Out of Nowhere
June 16, 2009
Web Exclusive: Solving a Medical Mystery
June 16, 2009 – Debu Tripathy, MD
Web Exclusive: Clinical Trials for CUP
June 16, 2009
Childhood Cancer Survivorship Programs
June 16, 2009
Chicken Soup for the Soul: The Cancer Book
June 15, 2009 – Kathy LaTour
Improved Care Needed for Patients Receiving Heart-Toxic Drugs
June 15, 2009 – Melissa Weber
Cancer Research Receives Infusion of Federal Funds
June 15, 2009 – Lacey Meyer
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Resources
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June 09, 2009 – Deirdre Carey
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Surgical Strategies
June 09, 2009 – Karen Patterson
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June 09, 2009 – Lacey Meyer
Weighing the Techniques
June 09, 2009 – Charlotte Huff
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June 09, 2009 – Katy Human
Hard Times
June 09, 2009 – Joanne Kenen
Reconstruction Do-Overs
June 09, 2009 – Kathy LaTour
Fighting Fatigue
June 09, 2009 – Lena Huang
Disjointed Custody
June 09, 2009 – Charlotte Huff
No I.D.
June 09, 2009 – Katy Human
ASCO Updates
June 09, 2009 – Staff Reports
Interventions Needed to Get Survivors Moving
June 09, 2009 – Lena Huang
The Financial Advocate
June 09, 2009 – Kathy LaTour
Ovarian Cancer Survivors Course
June 09, 2009
Q & A: Prostate Cancer Screening
June 09, 2009 – Len Lichtenfeld, MD
www.armyofwomen.org
June 09, 2009 – Elizabeth Whittington
With a Friend Like Will Ferrell...
June 09, 2009 – Lacey Meyer
Program Keeps Tabs on Childhood Cancer Survivors
June 09, 2009 – Lacey Meyer
Revisiting the Seasons of Survival
June 09, 2009 – Kenneth D. Miller, MD
Prostate, Brain & Kidney Cancers
June 09, 2009 – Elizabeth Whittington
A Life Beyond Cancer
June 09, 2009 – Renée La Forest
Good Grilling
June 09, 2009 – Lena Huang
Medical Devices Face Stricter Regulations
June 09, 2009 – Jo Cavallo
All Is Not Lost
June 09, 2009 – Lacey Meyer
Letters from Our Readers
June 09, 2009
Message from the Editor
June 09, 2009 – Debu Tripathy, MD
Targeted Therapy: Hope or Hype?
June 09, 2009 – Laura Beil
Conquering Cancer & the Classroom
June 09, 2009 – Scott Williams
Reining in Renal Cancer
June 09, 2009 – Karen Patterson

Smarter Trials for Smarter Drugs

Clinical trials of potential drugs are getting more sophisticated. 

BY Laura Beil
PUBLISHED June 09, 2009

In a traditional scientific study, the drug that saved Elizabeth Alexander’s life would have been deemed a failure. An associate professor of history at Texas Wesleyan University in Fort Worth, Alexander was diagnosed with metastatic HER2-positive breast cancer in 2000. She took Herceptin (trastuzumab), a drug that targets the HER2 molecule overproduced in about 20 percent of breast cancers.

“I think I’m really lucky,” she says. But the drug doesn’t work for most patients because their breast tumors don’t have a high enough density of the target. So in a typical clinical trial, which would enroll women at a certain stage of breast cancer, Herceptin would have been lost in the background noise, at least statistically. To detect even a slight benefit, one researcher noted, a study that included all breast cancer patients would have needed more than 23,000 subjects.

These and other studies reveal a challenge to testing experimental treatments: A drug might work in only 5 percent of patients, but in that 5 percent, it could be a home run. So clinical trials of potential drugs are getting more sophisticated, following the lead of Herceptin and other early targeted drugs. 

In Herceptin’s seminal study, researchers selected women whose tumors were known to have a high density of HER2, even though the HER2 test was not very refined at the time. Similarly, researchers today realize they need to know about the molecular makeup of each patient’s tumor before the study begins. Otherwise, a good drug might be lost—not because it doesn’t work, but because it was tested on the wrong tumors.

“We all realize ultimately the way we’re going to cure cancer is to match the right drugs with the right patients,” says Roy Herbst, MD, of M.D. Anderson Cancer Center in Houston. His institution and other cancer centers are beginning to test targeted drugs in a new way.

At M.D. Anderson, the approach is almost like four studies in one: advanced lung cancer patients randomly receive either Tarceva (erlotinib), Zactima (vandetanib), Nexavar (sorafenib), or a combination of Tarceva and Targretin (bexarotene). After eight weeks, each patient is evaluated. If the cancer hasn’t shown any improvement, patients can move to a different treatment. Along the way, researchers are studying the molecular properties of the tumor to understand why one treatment may outperform another. 

Other study designs call for patients who are stable to be randomized to either continue treatment or stop altogether, known as a randomized discontinuation study design. Together, these approaches are termed adaptive trial designs.

The idea of updating a study while it is still in progress is becoming more common and may ultimately be the best way to get answers about targeted drugs, Herbst says. “You sort them to the group most likely to benefit.” 

Such knowledge of tumors will also help after drugs are approved, keeping doctors from prescribing expensive and possibly harmful drugs to patients who are unlikely to benefit.

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