A chemotherapy regimen for patients with advanced bladder cancer who aren't eligible for standard treatment is under study at the Medical College of Georgia.
The unfortunate reality is that kidney problems often result from bladder cancer which precludes the usual chemotherapy package of cisplatin and gemcitabine, says Dr. Teresa A. Coleman, hematologist-oncologist at the MCG Cancer Center.
A Phase II study at about 120 sites in North America, Europe and Asia will determine if those patients can benefit from vinflunine, which is in the same vinca alkaloid family as Navelbine®, used for lung cancer.
These vinca alkaloids keep cells from dividing properly so the tumor can't grow and existing tumor regresses, says Dr. Coleman, a principal investigator on the study sponsored by Bristol-Myers Squibb.
Patients with stage two disease, which has spread beyond its origin in the bladder's lining, typically get cisplatin and gemcitabine before or after surgery or in conjunction with radiation therapy. However, a major side effect of cisplatin is kidney failure, and gemcitabine alone is believed not to be nearly as effective. “The most effective drug we have can't be used in some patients,” Dr. Coleman says.
Bladder cancer, the sixth most common cancer, often obstructs tubules that connect the kidney to the bladder, says Dr. Coleman. While the cancer typically doesn't spread upward, tubule blockage damages the kidneys. Additionally, bladder cancer incidence peaks in the 60s and 70s when other diseases, such as type 2 diabetes and uncontrolled blood pressure, may also have damaged the kidneys, she says. These scenarios make more than 50 percent of patients age 70 to 80 and an estimated 30 percent of all bladder cancer patients are ineligible for cisplatin.
“I see so many patients who come to my office with kidney damage for a variety of reasons, and I have little for them really,” says Dr. Coleman. A chemotherapy regimen that includes the drug carboplatin instead of cisplatin – both platinum-based compounds that also keep cancer cells from dividing – is more kidney friendly but less effective than the cisplatin regimen, studies have shown. Bristol-Myers Squibb produces cisplatin and carboplatin.
Participants will either get vinflunine and gemcitabine or gemcitabine alone. They will get the drug regimen intravenously on days one and eight of a 21-day cycle. Patients who do well may continue taking it up to a year or more.
Anemia is the major side effect of vinflunine, which suppresses the bone marrow, but existing anemia does not exclude patients from the trial, Dr. Coleman says.