Your Stories
We encourage Phase 1 Clinical Trial Volunteers and/or their supporters and Care Givers to submit personal experiences for inclusion on this portion of the website. This will assist those who are considering becoming a volunteer to have as much information as possible. Please submit your stories to info@researchwithrespect.ca . We will contact you for verification before we go live on the website with it.
 Dave’s Phase 1 Clinical Trial Experience: as recalled by his wife
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In early August, 2005, during an annual physical exam, our GP noticed that Dave was pale and sent him for blood work. Two days later, Dave received 2 blood transfusions and was scoped to see if the blood loss (detected in tests of his stool) was due to a re-occurrence of esophageal ulcers (’94).
We were told that Dave had advanced esophageal cancer that was inoperable. After further tests, we were told that the cancer had metastasized to his liver and lungs.
Dave had no pain and no difficulty swallowing – just overwhelming fatigue – but the news that his lungs were cancerous was devastating. Dave had been dealing with COPD for 15 years and so the prospect of even greater difficulty with his breathing was a psychologically crushing event.
During a subsequent visit to the GP, while Dave and the doctor were chatting about a second pathology report that hadn’t come in yet, I asked for a copy of the ultra-sound report. I do not know why that request popped into my head. The GP obliged. The report had the phrase “no pulmonary involvement.” I queried the GP as he had given us the results 2 weeks earlier. “Oh,” he said, “I must have been thinking of another patient.” That was a very good day – Dave had been cured of lung cancer!
In late Aug. 05, Dave was told that he could, possibly, have another 6 months to live. Dave’s situation was assessed by BCCA oncologists. He was put on dexamethasone. He was given morphine to have on hand to deal with the liver pain that we were assured would strike viciously some day soon.
He was put on what Dave called “happy” pills – a month later, the dose was doubled. He signed a “Do Not Resuscitate Order” as Dave opted to die at home. The oxygen condenser was moved into our home and the schedule for visits from the community nurse was being established.
In Oct. 05, Dave had 4 doses of low-radiation to cauterize the esophagus - to minimize the blood loss - but that’s all they could do for Dave.
Dave had seen an article in The Vancouver Sun newspaper, in September of ’05, re gene therapy being developed by a cancer researcher friend of our daughter. After contacting him, Dave was offered the possibility of joining a Phase 1 clinical trial. However, only a chemotherapy study was being offered.
Our nurse daughter and I tried to dissuade Dave from becoming involved with chemotherapy of any kind. Even Dave was convinced that the original oncology specialist’s advice was accurate - that chemotherapy would be ‘a lot of pain for no gain”.
But Dave saw the clinical trial as an opportunity to do something worthwhile with the last days of his life. It took so much out of him – traveling to Vancouver; going through the examinations and tests to see if he qualified to join the Phase 1 study.
The day before his 69th birthday, he was told that he had been accepted. We had a small birthday party and then went back to Vancouver to take up a month-long residency in a room that we had rented as it was a stipulation of the trial that Dave be in close proximity to the research facility for the first 30 days of the trial.
On Monday, November 21/05, Dave had the first infusion of CPX-1, at a dosage being tested on the 6th cohort of a proposed 8 cohort study.
I helped Dave get to the research facility every time a blood test was required - 16 times in the first week.
He was so very tired; but he dealt well with the side effects - a couple of bouts of diarrhea; the high doses of Imodium seemed to work.
He had been cautioned that contracting a respiratory infection was a concern, especially as it was ‘flu season’. So, because of fear and fatigue, we became quite isolated.
At the end of the first week, Dave’s swelling in his legs completely disappeared – overnight. No more wrestling with elastic stockings! We thought it was a good sign that the +2 edema that he had experienced since September, was gone.
On the Tuesday of the 2nd week of the trial, the diarrhea returned – frequent episodes and violent vomiting and retching incidents.
That afternoon, we got in to see the research doctor who ordered a couple of hours of IV hydration with Maxeran at their Ambulatory Daycare. That day was the last time a doctor from the research facility gave Dave a ‘hands on’ physical assessment and the only time the trial nurse saw Dave that week or ever again.
I borrowed a wheelchair to get Dave back to our rented room. That Tuesday was the last day that he ate food.
Each day for the next four days, I dressed Dave, bundled him up and trundled him over to the research facility by wheelchair for blood tests – shifting in and out of the car was too exhausting for him. On 3 of those days, I took him to the Ambulatory Daycare for a couple of hours of IV hydration. Every 2 hours I would make sure that he took the high doses of Imodium. Dave was sleeping a lot, so I had to wake him to take the medication.
Every day I phoned the trial nurse to express my concern – that was when the hydration sessions and stool test were arranged. She said that Dave must drink at least 8 oz. of fluid an hour, so I would have to disturb him 2 or 3 times an hour – except at night.
During those last few days, Dave didn’t like me very much. The Imodium just wasn’t working. Dave had diarrhea episodes 7 to 10 times a day. I moved him from his bed to the bathroom with a walker.
On the Thursday, I told the trial nurse that Dave was too ill; that we didn’t think he could have the second infusion of CPX-1 scheduled for Monday of the next week.
On Friday, again I went to her office, while Dave was having hydration, I was crying when I told her that Dave just could not have another infusion because he was so very sick. I met the trial doctor outside her office and told him Dave was so sick and that the Imodium wasn’t working.
He said to stop the Imodium and come in the next morning, Sat., for another mini-hydration. He introduced me to the resident who would cover for him on the weekend.
I stopped the Imodium that afternoon but Dave had a huge vomiting episode and 4 diarrhea incidents in an hour and a half when we got back from the hydration session. I put Dave back on Imodium – it actually was slowing the bowel movements down – but just to Level 4 chemotherapy-induced diarrhea. I found out later that the care guideline for cancer patients with Level 3 / 4 chemotherapy-induced diarrhea recommends that the patient be hospitalized immediately and administered 24 hour hydration until the diarrhea is controlled. Level 5 chemotherapy-induced diarrhea is death.
When we got to the Ambulatory Daycare on the Saturday morning, I asked for the doctor to come and see Dave. The doctor sat in a chair at the bottom of the bed that Dave was in while he was hooked up to the IV. The doctor said that the blood work of that morning showed that Dave’s kidney function had gotten much worse (280 creatinine) but that they didn’t have a bed for him.
The doctor told us to continue with the Imodium and to come back on the Sunday morning for more lab tests and another mini-hydration session.
Late Saturday afternoon, I phoned the research facility; spoke to the resident doctor and told him that I was concerned – that Dave was even weaker and that he wasn’t answering my questions correctly. The doctor said to bring him in again on Sunday morning.
The doctor was contacted again, about 10 pm, and was informed that Dave’s breathing was extremely laboured. The doctor said to stick with the plan to bring him into the research facility in the morning.
At 3 am on Sunday morning, I woke Dave up to give him the double dose of Imodium. Dave indicated that he needed to go to the toilet. I moved him onto the little seat on the walker but just as I was transferring him onto the toilet, he had a seizure. I couldn’t get him back onto the bed. I called for help and 911 were phoned.
As we were just 2 blocks from VGH, the ambulance was there within minutes. Dave was breathing and I insisted that everything possible was done for him.
VGH Emergency was so caring of Dave. But the soles of his feet were black; his creatinine level was 505; his breathing was raucous as he had acidosis (blood turned to acid) and he was terribly agitated.
Dave was taken to be X-rayed and after that effort he never made another meaningful sound or gesture. The research facility’s resident oncologist dropped into VGH Emerg twice that day and both times he told me that they could get Dave “over this hump”.
The VGH kidney specialist told me that dialysis was not an option as Dave’s capillary system had shut down. He was given morphine to ease his breathing.
At 6 pm, that Sunday, blood poured out of his mouth and nose and he died.
I asked the research facility if the clinical study needed Dave’s body. The doctor sounded appalled that I would ask that question and replied, “No, it wasn’t needed.”
Later, I asked the research facility about the level of care that they provided. They said that they were sorry that the level of care did not meet our expectations - they judged the level of care that they provided to Dave was “reasonable” and “adequate”.
I asked the research facility’s Ethics Board if the protocol (plan of action) for the clinical trial was detailed enough. The Ethics Board Chairman wrote, “My finding is that the deficiency in this case was not with the procedures that are in place but rather that those procedures were not always followed.”
The ‘safe’ dose of CPX-1 was determined to be the dosage administered to the 5th cohort of the Phase 1 clinical trial process. The Phase 2 clinical trials of CPX-1 are currently in progress – but not in Vancouver.
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Knowledge gained in your experiences can help others. Please submit your stories to info@researchwithrespect.ca. We will contact you for verification before we go live on the website with it.
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