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Erie's Regional Cancer Center Conducts First Phase 2 Clinical Trial

Erie's Regional Cancer Center Conducts First Phase 2 Clinical Trial [Erie Times-News, Pa.]

From Erie Times-News (PA) (October 15, 2010)

Oct. 15--Marlene Mizikowski is making history at the Regional Cancer Center.

That’s fine with her, but the 71-year-old Erie woman has one other thing on her mind: Survival.

Doctors diagnosed Mizikowski in May with advanced lung cancer, one of the deadliest types of cancer. Just 16 percent of people with the disease live five years or longer after diagnosis.

"The way I figure, it can’t get any worse," Mizikowski said. "If there is something that can help, I will do it."

That something is aflibercept, an intravenous cancer drug Mizikowski calls "flibber" that shrinks tumors by cutting off their blood supply.

She receives aflibercept as a participant in the Cancer Center’s first Phase 2 clinical trial.

Once every three weeks, Mizikowski goes to the Cancer Center to receive aflibercept as part of her nearly daylong chemotherapy treatment.

"It’s in addition to traditional chemotherapy," said Jan Rothman, M.D., Mizikowski’s medical oncologist at the Cancer Center. "What this drug does is shrink tumors without any of the significant toxicity of the drugs that are now used."

Clinical trials are how new medications and treatments are tested. Phase 2 trials are done to determine how well the drug or treatment works.

The Regional Cancer Center had never hosted a Phase 2 clinical trial before, Rothman said.

Hosting more clinical trials was one reason why Hamot Medical Center and Saint Vincent Health Center brought in UPMC Cancer Centers to manage the Millcreek Township facility.

"We want to offer patients any new and available drugs to give them the best chance possible to fight their disease," Rothman said. "If a drug looks promising and effective but it’s not proven, patients are willing to take a certain risk."

And there are risks. Another RCC patient who started taking aflibercept shortly after Mizikowski did in May had to be removed from the trial because of serious side effects, Rothman said.

Mizikowski is also suffering side effects from her treatment, but she said she doesn’t know if it’s from aflibercept or the traditional chemotherapy drugs she also takes.

"My first treatment was the worst," Mizikowski said. "I got really nauseous and lost 10 pounds because I couldn’t eat anything for eight days."

Mizikowski wasn’t sure if she wanted to continue the treatment, but her grown children convinced her to stick with it.

The succeeding treatments didn’t cause her as much discomfort.

"Now I come back and get IV fluids the next day, and that helps," Mizikowski said. "I still feel weak and fatigued for a good week to 10 days after each treatment. It’s tolerable, though."

Mizikowski’s treatment doesn’t look any different from typical chemotherapy. She sits in a chair while the IV drugs slowly drip into her body through a port near her collarbone.

But the Cancer Center worked for more than a year to bring this Phase 2 clinical trial to Erie.

One of the drug companies that produces aflibercept, Regeneron Pharmaceuticals, approached the RCC during the summer of 2008 and asked if it wanted to host a Phase 2 trial.

Aflibercept was already being used to treat patients with other types of cancer, now a clinical trial was created to see how it could benefit lung-cancer patients, Rothman said.

But before any RCC patients could enroll in the clinical trial, the center had to pass its own test for Regeneron to approve it as a site. The drug company sent a lengthy questionnaire and later inspected the Cancer Center.

"We didn’t have to make any physical changes to the Cancer Center, but preparing for Phase 2 trials involved almost every department in the building," said Mary Lynn Haynes, R.N., RCC’s clinical research coordinator. "We had to educate the people in billing, oncology nurses, physicians, lots of people."

The Cancer Center was permitted to begin the Phase 2 trial in April. Mizikowski is currently the only patient enrolled.

"The screening process is tough," Rothman said. "The patient must have advanced non-small cell lung cancer. They must be functionally active, not bedridden. They must not have had a recent stroke, heart attack or thrombosis."

Hosting a Phase 2 clinical trial will give the Cancer Center valuable experience if the Food and Drug Administration approves the late John Kanzius’ external radio-wave generator as an experimental cancer treatment.

Steven Curley, M.D., lead researcher on the Kanzius project at M.D. Anderson Cancer Center in Houston, has promised that the Cancer Center would host a Phase 2 trial for the device.

It is "very important that the RCC has some experience with human clinical trials," Curley said in an e-mail. "The patient care and data management is critical."

The Cancer Center is also in talks with the drug manufacturer Pfizer Inc. to host a hybrid Phase 1-2 clinical trial for a different lung-cancer drug.

Pfizer representatives will soon visit the Cancer Center for a site inspection, Rothman said.

The Phase 2 trial for aflibercept is expected to run for at least several more years. Mizikowski is scheduled to receive two more aflibercept treatments with traditional chemotherapy, then Rothman will decide if she will receive the drug without chemotherapy.

"She will take it as long as it works and she doesn’t have side effects," Rothman said.

And the drug is working. CT scans show that Mizikowski’s lung tumors are shrinking.

But aflibercept is not a cure. The best hope it offers is that it buys lung-cancer patients more time to spend with loved ones.

"I’ll keep taking it until they tell me it’s hopeless," Mizikowski said. "Then I will live as best that I can."

DAVID BRUCE can be reached at 870-1736 or by e-mail.

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Posted: October 2010