Good-Natured Texan Chooses ALIMTA Trial

At his family's urging, 54 year-old Texas small business owner Jim Dougherty saw his doctor in May, 1999 for what Jim calls "one of those over-50 physicals." He had some pain radiating from his right buttocks and leg, and also some weight loss. Jim figured the pain was from "just getting old", but he could ill afford to lose weight off an already slender frame.

X-ray films revealed the source of the pain: a ruptured disc in Jim's lower back. His doctor referred Jim to an orthopedic specialist. When the orthopedist's nurse examined Jim generally, she heard something in his right lung area. Jim's orthopedist advised him to get a chest film. Jim went to another local doctor, who took a chest film and immediately referred Jim to a pulmonologist. On July 8, the pulmonologist drained fluid from Jim's right chest cavity via thoracentesis. The pulmonologist referred Jim to a cardiothoracic surgeon.

The cardiothoracic surgeon admitted Jim to a small hospital in Bedford, Texas. The surgeon harvested biopsy material from Jim's right chest cavity via thoracotomy. The surgeon drained the fluid and performed a talc pleurodesis. Afterward, the surgeon told Jim that the tumor was too large and diffuse and could not be removed surgically. Pathological testing on the biopsy material confirmed the diagnosis of malignant mesothelioma on July 30, 1999.

A local oncologist recommended that Jim participate in a single, blind, randomized Phase III trial of a multi-targeted antifolate (ALIMTA (R) (pemetrexed disodium)) plus Cisplatin, versus Cisplatin only. In other words, patients would not know whether they were receiving ALIMTA and Cisplatin, or Cisplatin only. Jim found the "blind" aspect of this trial unacceptable. Through research, Jim found a Phase II clinical trial of the investigational anticancer drug, LY231514. The Phase II trial is being conducted at MD Anderson in Houston and will include 15 mesothelioma patients. The purpose of the study is to learn if LY23114 (an "anti-folate" compound) drug can shrink or slow mesothelioma.

According to Jim's understanding from his review of the literature, an "antifolate" is a folic acid antagonist with potent anti-tumor activity (as demonstrated in test tubes and in animals). Jim learned that ALIMTA had shown potential in attacking tumor cells in phase I trials. One 1998 phase II study reported that ALIMTA demonstrated "an encouraging response rate for ALIMTA" in patients with locally recurrent or metastatic breast cancer. Another 1998 phase II study found that ALIMTA had "definitive anti-tumor activity" in advanced transitional cell carcinoma of the bladder, but with "significant" toxicity.

According to Jim, in a nutshell, here is how the treatment works:

Patients receive the antifolate through a needle into the vein of the arm. Administration of the antifolate takes about ten minutes. (However, other drugs and/or solutions are administered for about four and one-half hours.). The patient receives the antifolate this way every 21 days (one cycle). The patient may also receive anti-nausea medicine.

Patients will take a medicine called dexamethasone (in pill form) to guard against skin rash that often occurs with use of the anti-folate.

Every week after the first visit, the patient will return for blood tests. A CT scan will be repeated every 4 to 6 weeks to see how the tumor is responding to the treatment.

The patient can be taken off the study for a number of reasons by his own choice or at the advice of the doctors of sponsors. There is no maximum time that a patient can take the drug.

Treatment is on an out-patient basis. The patient does not need to be admitted into the hospital.

Jim was very reluctant to participate in the trial. He felt that "if it is a trial, then it must not really work." Jim asked us if we knew anything about MTA and we suggested he contact Charley and Fran Baker, who believe that MTA has helped reduce or at least stabilize Charley's pleural mesothelioma. Before his treatment with ALIMTA, Charley had sweating, labored breathing and little energy. Now that the sweating is gone, Charley breathes much easier, and he has resumed a more normal lifestyle.

After speaking with the Bakers, whom Jim calls "wonderful, wonderful people", Jim decided to participate in the LY231514 trial at M.D. Anderson Hospital. The ALIMTA trial is not being advertised publicly by the pharmaceutical company or the hospital. Jim learned about it through a relative who has connections in the medical community. After his first treatment, Jim reports that he feels "a little tired, but fine, really." He says that M.D. Anderson administers an anti-nausea cocktail that so far has worked.

Jim Dougherty has a wonderfully complex personality. He is crusty ("I don't go in for all that 'poor me' and sympathy crap!"), but warm and friendly at the same time. He has a healthy distaste for politicians (and lawyers), but he's a bit of a politician himself: he served on his local village council for six years, and served another two years as mayor of the village. I find myself calling Jim Dougherty to make myself feel good. He has a wonderful way of disagreeing vehemently with you, but without spite. He likes to visit his neighbors ("My constituents!") in an old golf cart he tools around in. He likes to drink beer and fish. He loves his daughters, and above all, his wife Mary. He'll joke about almost anything, but when it comes to the matter of Mary's future, Jim is dead serious. "I wouldn't be doing any of this if it wasn't for Mary."

Jim has been refreshingly upbeat about his prospects. He knows that the medical community has not found the magic bullet for mesothelioma, but among all the options he feels that ALIMTA is the best course for him to take. He is realistic above all else. He says jokingly that even if his body begins to deteriorate, "the last thing to go will be my sense of humor." We hope Jim can outwit his disease. We'll keep you posted on his progress.

*** POSTED OCTOBER 11, 1999 ***

An Update -- 9/4/01

James Dougherty calls himself "one of the lucky ones." After a slight resumption of growth in his tumor, he was no longer eligible for the ALIMTA trials in which he had been participating. However, he continues taking Gemzar and Cisplatin for his weekly chemotherapy treatments, and he spends his time relaxing, as he's "wiped out" by one o'clock. The transplanted Yankee maintains a positive attitude, a lively spirit, and looks forward to seeing another day. He takes OxyContin to alleviate his pain.

An Update -- 7/24/02

Jim complains that side effects of chemotherapy such as loss of hearing and numbness in his extremities are worsening. CT scans have shown that his tumor has not decreased in size.

Mr. Dougherty passed away on October 17, 2003