News & Information | START In The News

June 28th, 2010
San Antonio Business Journal

Lung cancer clinical trials in San Antonio

Editor’s note: It’s no secret that lung cancer is the leading cause of cancer deaths among both men and women. There were an estimated 159,000 deaths from lung cancer in 2009.

In San Antonio, serious work is being done to to fight cancer. A search of the National Cancer Institute’s Web site found that there are currently 235 clinical trials under way in the Alamo City — 31 of which targeted lung cancer. That doesn’t count several studies that are or will soon be accepting patients.

For example, at the Cancer Therapy and Research Center, a Phase III study evaluating Stimuvax, a vaccine designed to induce an immune response to certain cancer cells, was put on hold, but is expected to re-open soon.

Also, in August, ImClone, a subsidiary of Eli Lilly, will sponsor a study at the START Center for Cancer Care. The Phase II study will evaluate a new drug known to block blood vessels that feed cancer in combination with chemotherapy in patients with advanced non-small cell lung cancer.

In some cases, a study may not be listed at a location where a trial is taking place, so clinical trial organizers advise patients to check with the centers as well. For instance, you won’t find San Antonio listed as a site for a Phase I/II randomized study of Erlotinib with or without Crizotnib, but Epp Goodwin, patient coordinator for CTRC, says the center is accepting patients for the study.

Following are summaries of two studies that are listed on the NCI Web site.

Drug name: BAY 73-4506, also known as regorafenib.

Location: South Texas Accelerated Research Therapeutics

Investigator: Kyriakos Papadopoulos, M.D.

Sponsor: Bayer Corporation
Phase I

Main inclusion criteria includes: Adult patients with advanced, histologically or cytologically confirmed solid tumors, malignant lymphomas, or multiple myeloma refractory to any standard therapy; life expectancy of at least 12 weeks; adequate cardiovascular, bone marrow, liver and renal function

Summary: At the 2010 American Society of Clinical Oncology, START’s Anthony Tolcher, M.D., was among the study authors that presented results of a clinical trial on regorafenib. The drug was administered orally and continuously (21 day on; 7 days off) to patients with advanced refractory non-small cell lung cancer. The study was to assess safety, efficacy and pharmacokinetics — or how the drug affects, is absorbed and excreted by the body. According to the presentation, in animal models, regorafenib showed “a broad spectrum of antitumor activity,” according to the authors. In addition, a Phase II study of the drug in patients with metastiatic renal cell (kidney) cancer resulted in a 31 percent partial response rate.

In this study, 21 patients — all of which had had some type of chemotherapy in the past, were given regorafenib. The median treatment duration was 84 days, the range being 12 to 281. Of 17 evaluable patients, 13, or 76 percent, had stable disease at least six weeks after treatment.
Study conclusions: “Regorafenib, dosed continuously at 100 mg, was well tolerated in patients with advanced refractory non-small cell lung cancer. Promising clinical activity was shown, with a disease control rate of 76 percent in evaluable patients,” the authors noted in the ASCO presentation.

Drug name: REOLYSIN, given in combination with Paclitaxel and Carboplatin in patients with squamous cell carcinoma of the lung

Location: Cancer Therapy and Research Center

Investigator: Alain Mita, M.D.

Sponsor: Oncolytics Biotech Inc.

Phase II

Main inclusion criteria includes: Have histologically or cytologically confirmed metastatic stage IIIB of stage IV, or recurrent squamous cell carcinoma of the lung; be chemotherapy naive for metastatic or recurrent episode, with some exceptions; life expectancy of at least three months

Summary: It’s not the first time CTRC has studied a virus’ impact on cancers. In fact, it currently has three trials open — advanced pancreatic cancer, metastatic melanoma, and head and neck cancer — all using REOLYSYN in combination with chemotherapy drugs. In April, it began a study of REOLYSIN, a treatment derived from the reovirus, in combination with the chemotherapy drugs Paclitaxel and Carboplatin.

Alain Mita, M.D., says currently chemotherapy drugs alone do not typically cure the disease.

“The study offers new hope for this group of patients with lung cancer,” he says.

This study is designed to test the efficacy and safety of REOLYSIN given intravenously in combination with the two common chemotherapy drugs every three weeks, according to the National Cancer Institute.

According to CTRC, as many as 55 patients are expected to enroll in the study.