New Clinical Trial

[smokeyjoe]

The other thing that comes to mind with this combo. is .....did these people take the drugs for a certain amount of time and achieve remission, and were able to stop taking the chemo. Or, are these patients on continual chemo. to control the cancer. That isn't mentioned at all, perhaps it's a mixture, like everyone responds differently. I saw the article and one woman is ten years out of stage 1V diagnosis, has she been on chemo. all this time, or has she been in remission. Just wish there was more DETAILS!!!

[CheeseHead]

Yes, questions...

Let's just hope we get some more details here and it turns out to be as good as it seems.

[Laurettas]

I posted a link a couple of weeks ago to an article about this treatment. I know that one woman was in treatment for awhile--maybe three years--and then went off treatment and had been that way for three years at the time the interview was given.

I just went back and reviewed the article. This woman was in her early 30's when diagnosed, had surgery, then two recurrences in her lymph nodes, a few weeks of radiation after the second recurrence, on the Xeloda/Celebrex combo for I think three years and then three years with nothing. Pretty amazing!

One woman said that she was taking the combo of one week on Xeloda and one week off and I don't know the Celebrex schedule but said that she had basically no side effects and was living a very normal life.

Here is a link if you would like to read or listen to the talk about these women:

http://www.patientpower.info/program/me ... transcript

[very worried husband]

Pretty impressive stuff.... Thanks Laurettas

[Fede]

Hi, Laurettas a great friend... in this journey you are an example in this fight....

Two last days thinking in you, GREAT RESEARCH YOU DID... I love it. I think we had all a huge hope on it.

As I wrote before, you know that I were/am financial analyst in the New York Stock Exchange, so I see a hide value in Pfizer, I don t know the motive the catalyst, but investors are showing something interesting, of course PFE Pfizer has a large med portfolio, and we are talking about phase II trial, but I am not interesting in the business or give a recommendation... clearly, the news is increible, and believable supported by Pfizer and Bristol Mayer, using the hand of Genentech (Avastin).

I believe we should continue looking at the progress nearly...

The rare thing here ... it why this conclusions have not a big marketing ? why? who is M.D Lin?

BUT THE HOPE IS BIG FOR EVERYBODY HERE....

Laurettas my friend, you are making an excellent research my congratulations.

A kiss for you.

Fede

[Laurettas]

Fede, that is very interesting about Pfizer. I went online and looked up a little about them and it sounded like they have been having somewhat of a difficult time economically. It would be interesting to know what is spurring all of the financial interest in them, wouldn't it?! Keep looking and listening and maybe you can find out some good news for all of us!

[RixInPhx]

Pfizer was just hit by the US Feds with a huge fine ($2.3 Billion total, criminal and civil) essentially for bribing docs to prescribe their products. Pfizer will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the U.S.
http://www.businessweek.com/bwdaily/dnf ... 913433.htm

And now there are new charges that they played around with release of Liptor to generic status.

Not real good news for large stockholders.

[Fede]

Rix, exactly Pfizer had a lot of problems specially its style, but perhaps it made a pressure to launch asap some hidden card as far as the Phase II trial, wich if it continue in this line, will be something explosive.

Laurettas, I will look at the movements and each steps about it.

A huge hug for both

Fede

[miabella1]

I printed this out and took it to my oncologist when I had my appointment on Monday, at MD Anderson. Dr. Lin was a doctor at MDA before relocating to Seattle. My doctor contacted Dr. Lin that day, and arranged for me to have a consult with Dr. Lin. I will be seeing him on August 14th.

[Laurettas]

So excited for you, Miabella! Please let us know what he has to say.

If you don't mind my asking, what is the current state of your cancer? Is it stable now? Have you progressed on all standard of care treatments?

[Fede]

I printed this out and took it to my oncologist when I had my appointment on Monday, at MD Anderson. Dr. Lin was a doctor at MDA before relocating to Seattle. My doctor contacted Dr. Lin that day, and arranged for me to have a consult with Dr. Lin. I will be seeing him on August 14th.

Please miabella, We all waiting for your feedback, we have a huge hope, I will thank you a lot if you can give us a feedback,

Thanks in advance.

I hope the best for you

Fede

[miabella1]

Below is a copy of the doctor's notes from my last visit. It will give you a brief history of my illness and let you know where I am now.

07/09/2012

Diagnosis: Metastatic unknown primary cancer (likely colon).

Current Treatment: Currently on 5-fluorouracil.

Oncologic History:
1. On 01/10/2011, exploratory laparotomy, lysis of adhesions, removal of ascites and ileostomy. Operative findings showed significant carcinomatosis without normal bowel seen. Pathology showed small bowel mesentery biopsy, omental cake biopsy, and peritoneal nodule excisional biopsy, all with poorly differentiated mucinous adenocarcinoma with signet ring cell features involving fibroadipose tissue, morphologically consistent with tumor arising in the upper GI tract or appendix. Ascitic fluid was also analyzing and an adenocarcinoma with signet ring cell features was seen. The patient had postoperative wound healing difficulties.
2. In 01/2011, epirubicin, 5-fluorouracil, oxaliplatin, and leucovorin. The patient had difficulty with nausea and only had 1 cycle.
3. From 02/11/2011 through 04/11/2011, chemotherapy changed to FOLFOX-6, status post 5 cycles with disease response.
4. From 05/04/2011 through 06/20/2011, reinitiated on FOLFOX. Bevacizumab was added on 05/23/2012 but discontinued after 2 cycles due to Dr. Fogelman not feeling that there was any added benefit.
5. The patient was switched to 5-fluorouracil maintenance on 06/20/2011. Treatment was changed to FOLFIRI and bevacizumab at 07/25/2011 due to clinical progression with abdominal pain.
6. Restaging on 11/11/2001 shows stable disease, some elevation in transaminases, and treatment was changed to FOLFIRI plus cetuximab (KRAS wild type) with potential discontinuation of irinotecan anticipated.
7. Since 04/09/2012, the patient has been on single-agent irinotecan due to hypomagnesemia as well as fissuring of her skin. She is here for restaging evaluation today.
8. At restaging evaluation on 05/21/12, the patient was switched to single agent 5-fluorouracil.

History of Present Illness and Review of Systems: Mrs. Church is a 54-year-old female with a history of metastatic unknown primary cancer. She is currently on 5-fluorouracil and presents today in clinic for restaging evaluation with CT scans and labs. She notes currently tolerating the chemotherapy well. She does note some nausea associated with the chemotherapy, which is controlled by Zofran tablets. She does also note some occasional mouth sores that have since resolved. She also has occasional foot syndrome, in which her feet turn red and swollen. She sometimes has pain associated with walking and notes that this is gradual and fluctuates. She normally has to empty her ileostomy bag about 6-8 times a day. She does note that her diarrhea is worse on days 1 through 4 of chemotherapy, in which she uses Lomotil tablets to control this. She has noted a weight gain since last fall of 40 pounds. She notes she is working on improving her diet and increasing her activity level. She continues to remain active; however, this is controlled by whether or not she has fatigue. She also does note some sporadic right upper quadrant pain that has been there for about 3 months. She notes that it occurs randomly and that it feels like a pulling or burning pain. Occasionally she will have a sharp pain that radiates to the back. She notes movement helps with this pain. She currently is not taking any pain medication for the abdominal pain. She reports this is unchanged since prior visits. She denies any fever or chills. She denies any chest pain, shortness of breath, edema of the lower extremities or any neuropathy of the hands or feet. She is otherwise doing well at this time and has no further complaints.

Allergies:
1. PLASTIC TAPE.

Medications:
1. Aspirin.
2. Ativan.
2. Cyclobenzaprine.
4. Prozac.
5. Lac-Hydrin.
6. Lisinopril/hydrochlorothiazide.
7. Lomotil.
8. Loperamide.
9. Lovenox.
10. Magic mouthwash.
11. Magnesium
12. Marinol.
13. Melatonin.
14. Ondansetron.
15. Promethazine.
16. Tagamet.
17. Vitamin B6.
18. Vitamin D.


Physical Examination:
General: This is a pleasant 54-year-old female who appears her stated age and is well nourished. She is alert and oriented x3 and is in no acute distress. Performance status is approximately 1.
Vital Signs: Temperature 36.7 degrees Celsius, pulse 94, respirations 16, blood pressure 136/89, height 161 cm, and weight 87 kg.
HEENT: Head normocephalic, atraumatic. Sclerae anicteric. Mouth: Mucosa is pink and moist. No mouth sores noted.
Neck: Soft and supple. No palpable cervical or supraclavicular lymphadenopathy.
Cardiovascular: Regular rate and rhythm.
Lungs: Clear to auscultation bilaterally.
Abdomen: Positive bowel sounds. Soft, nondistended, and nontender to palpation. No rebound or guarding.
Extremities: No cyanosis, clubbing, or edema.
Skin: No rash, pallor or jaundice. No hyperpigmentation spots on the palms or soles of feet. She does have some slight redness of the soles of the feet.
Neurologic: Grossly intact.


Laboratory Data: White blood cell count 5.2, hemoglobin 13.2, hematocrit 39.4, platelets 268,000, and neutrophil absolute count 3.42, total protein 7.6, albumin 4.5, calcium 9.6, phosphorus 4.5, glucose 88, BUN 16, creatinine 0.96, uric acid 5.9, bilirubin total 0.7, alkaline phosphatase 16, lactate dehydrogenase 512, alanine aminotransferase 65, sodium 138, potassium 4.3, chloride 102, carbon dioxide 24, magnesium 1.9, bilirubin indirect 0.5, bilirubin direct 0.2, aspartate aminotransferase 27.

Radiology Reports: CT scan of the chest shows no abnormally enlarged hilar or axillary nodes. There is a stable, slightly prominent right paratracheal node, stable back to 04/25/2011 which remains nonspecific. There is also a stable tiny subcentimeter subpleural nodule in the right upper lobe, stable back to 04/25/2011 which remains nonspecific and likely benign. No new pulmonary nodules or masses are identified. No evidence of pleural effusion. Impression: No definite evidence of metastatic disease, no change. CT scan of the abdomen and pelvis shows the liver is generally low density, consistent with fatty infiltration within these limits. Liver, spleen, pancreas, adrenals, and both kidneys remain unremarkable. No focal liver or splenic lesions identified. No splenomegaly or hydronephrosis. The gallbladder appears grossly unremarkable. No evidence of biliary or pancreatic duct dilatation. No abnormally enlarged retrocrural, anterior, diaphragmatic, retroperitoneal, mesenteric, pelvic, or inguinal nodes are identified. Some stranding is noted in the peritoneum in the right lower quadrant, stable compared to 05/18/2012, subjectively improved compared to 04/25/2011 nonspecific, possibly related to resolving post surgical change or responding metastatic disease. No ascites or intestinal obstruction identified. Scattered subcutaneous nodules are noted in the anterior abdominal wall, presumably related to injection site. Impression: Minimal stranding in the peritoneum adjacent to the site of the stoma stable compared to 05/18/2012, subjectively improved compared to 04/25/2011 nonspecific, possibly related to resolving post surgical change versus responding peritoneal metastatic disease.


Assessment: Mrs. Church is a 54-year-old female who has metastatic unknown primary cancer, likely colon cancer, who is currently on 5-fluorouracil chemotherapy. She presents today in clinic for restaging evaluation with labs and scans. At this time, she notes tolerating her current chemotherapy rather well with the exception of experiencing some occasional nausea, which is controlled with Zofran, occasional mouth sores, and increased output of the ileostomy, in which she takes Lomotil tablets for. She does also note some occasional painful feet with reddening of the skin, which is gradual and fluctuates from time to time. Her current CT scans show no evidence of metastatic disease in the chest and in the abdomen and pelvis shows minimal stranding in the peritoneum adjacent to the site of the stoma that is stable when compared to the last CT scan, which might be related to post surgical change or responding peritoneal metastatic disease.

Plan:
1. Metastatic unknown primary cancer. At this time, we will continue the patient on her current chemotherapy of 5-fluorouracil. However, she would like to schedule a consult for a clinical trial in Seattle with Dr. Lin. This clinical trial is a phase II study with Celebrex and capecitabine. We have e-mailed Dr. Lin to get in touch with the patient on whether or not she qualifies for this clinical trial. We will also have the patient consult with Dr. Sugarbaker to assess whether surgical resection is an option at this point. We will have the patient return to clinic in 4 weeks on 08/06/2012 for a toxicity check with routine labs at that time.
2. History of pulmonary embolism. At this time, we will continue the patient on Lovenox 120 mg subcutaneously daily. The patient was advised to continue on her Lovenox due to being at risk for another blood clot in the future.
3. We will schedule a colonoscopy for this patient. Her last colonoscopy she noted was about 18 months ago.
4. Weight gain.
5. Fibromyalgia. The patient was given a new prescription for Flexeril 5 mg, take 1-2 tablets p.o. q8hrs, dispense #120 with 0 refills.
6. Performance status is approximately 1.
7. Follow-up. The patient will follow up with Dr. F. in clinic on 08/06/2012 for toxicity check with routine labs.

The results of the labs and CT scans were discussed with the patient during today's visit. The patient's questions were addressed and answered as well. The patient was also seen today by Dr. F., who agrees with the plan noted above. know what my status is now.

[miabella1]

Edited, double post.

[miabella1]

Edited, triple post. Sorry peeps long post and you didn't need to see it three times.

[Laurettas]

Thank you, Miabella, for all of the information about your cancer. It sounds like you are doing quite well considering they don't know where your cancer started! I hope that you are eligible for the trial and that all goes well.