THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net


S U M M A R Y


DIARY: May 31, 2007 08:20 AM Thursday; Rod Welch

Millie at UCSF 2nd treatment 5th cycle cetuximab for 3rd relapse IBC.

1...Summary/Objective
2...Infusion Clinic for Cetuximab Treatent
..........Taxotere Capecitabine
..........Cetuxiab Clinical Study
3...Nurses Notes...
4...Side Effects Minimal...
........1...Rash acne-like
........2...Dry skin face, chest arm
........3...Dizziness Symptoms Enlarged Right Ventricle Cor Pulmonale
........4...Lymphedema Cellulitis Complications None Evident
............Inflammation Erratic Upper Left Arm Side Effects Cetuximab
........5...Tired, fatigued - pulmonary emoblism
........6...Heavy chest - shortness of breathing
........7...Cough - clearing throat
5...Schedule Weekly Treatments Continue on Thursdays
6...Preparation for Treatment Required One (1) Attempt to Connect Port
7...Blood Draw Flow Sluggish from Port Catheter
8...Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
9...Cetuximab Full Dose Blood Counts Below Targets Treatment 1 Hour
10...Vitals Show Patient Stable
11...Energy Normal Stable After Treatment Cetuximab Support Drugs

ACTION ITEMS.................. Click here to comment!

1...Catherine advised that when problems drawing blood from a port

CONTACTS 

SUBJECTS
Cetuximab 5th Cycle 2nd Treatment 18th Total Treatment Chemotherapy

0903 -
0903 -    ..
0904 - Summary/Objective
0905 -
090501 - Follow up ref SDS 76 0000. ref SDS 73 0000.
090502 -
090503 - Millie received the 2nd treatment of the 5th cycle, making 18 total
090504 - treatments with cetuximab chemotherapy on clinical study at UCSF.
090505 - ref SDS 0 7T3H  Side effects remain mild. ref SDS 0 QU8K
090506 -
090507 -
090509 -  ..
0906 -
0907 -
0908 - Progress
0909 -
090901 - Infusion Clinic for Cetuximab Treatent
090902 -
090903 - Follow up ref SDS 76 1M6H, ref SDS 73 1M6H.
090905 -  ..
090906 - Agenda...
090907 -
090908 -    1.  Side effects.............................. ref SDS 0 QU8K
090909 -    2.  Treatment cetuximab....................... ref SDS 0 4N5M
090910 -    3.  Vitals.................................... ref SDS 0 AW4L
090911 -    4.  Energy after treatment.................... ref SDS 0 F54N
090913 -  ..
090914 - Millie received 18th overall and 2nd treatment of 5th cycle with
090915 - cetuximab, starting from 070201, ref SDS 38 G68I, and the 25th
090916 - treatment for 3rd relapse of IBC, beginning on 060721. ref SDS 17 407N
090918 -  ..
090919 - Catherine was the nurse today.
090921 -           ..
090922 -          Taxotere Capecitabine
090923 -
090924 -          Follow up ref SDS 76 PR8Q, ref SDS 73 PR8Q.
090925 -
090926 -                   Relapse Treatments
090927 -
090928 -      1.  Cycle 09 and 01 ................... 060721, ref SDS 17 407N
090929 -      2.  Cycle 10 and 02 ................... 060814, ref SDS 21 LY6O
090930 -      3.  Cycle 11 and 03 ................... 060908, ref SDS 22 407N
090931 -      4.  Cycle 12 and 04 ................... 060929, ref SDS 23 407N
090932 -      5.  Cycle 13 and 05 ................... 061020, ref SDS 29 407N
090933 -      6.  Cycle 14 and 06 ................... 061110, ref SDS 31 407N
090934 -      7.  Cycle 15 and 07 ................... 061201, ref SDS 32 407N
090936 -           ..
090937 -          Cetuxiab Clinical Study
090938 -
090939 -          Follow up ref SDS 76 7T3H, ref SDS 73 7T3H.
090940 -
090941 -                   Total    Cetuximab
090942 -      8.  Cycle 01 and 08 and 01 01.......... 070201, ref SDS 38 SG8I
090943 -      9.  Cycle 01 and 08 and 02 02.......... 070208, ref SDS 40 SG8I
090944 -     10.  Cycle 01 and 08 and 03 03.......... 070215, ref SDS 41 SG8I
090945 -     11.  Cycle 01 and 08 and 04 04.......... 070222, ref SDS 43 SG8I
090946 -     12.  Cycle 02 and 09 and 01 05.......... 070301, ref SDS 46 SG8I
090947 -     13.  Cycle 02 and 09 and 02 06.......... 070308, ref SDS 48 7T3H
090948 -     14.  Cycle 02 and 09 and 03 07.......... 070315, ref SDS 52 7T3H
090949 -     15.  Cycle 02 and 09 and 04 08.......... 070322, ref SDS 53 7T3H
090950 -     16.  Cycle 03 and 10 and 01 09.......... 070329, ref SDS 56 7T3H
090951 -     17.  Cycle 03 and 10 and 02 10.......... 070405, ref SDS 59 7T3H
090952 -     18.  Cycle 03 and 10 and 03 11.......... 070412, ref SDS 61 7T3H
090953 -     19.  Cycle 03 and 10 and 04 12.......... 070419, ref SDS 63 7T3H
090954 -     20.  Cycle 04 and 11 and 01 13.......... 070426, ref SDS 66 7T3H
090955 -     21.  Cycle 04 and 11 and 02 14.......... 070503, ref SDS 68 7T3H
090956 -     22.  Cycle 04 and 11 and 03 15.......... 070510, ref SDS 70 7T3H
090957 -     23.  Cycle 04 and 11 and 04 16.......... 070517, ref SDS 73 7T3H
090958 -     24.  Cycle 05 and 12 and 01 17.......... 070524, ref SDS 76 7T3H
090959 -     25.  Cycle 05 and 12 and 02 18.......... 070531, ref SDS 0 7T3H
090961 -  ..
090962 - Nurses Notes...
090973 -  ..
090974 - Why is the visit number constant in Nurse's Notes, and yet seems to
090975 - vary in the schedule received from Nola on 070315? ref SDS 52 159O
090977 -     ..
090978 -    UCSF Log Time...
090979 -
090980 -                   Blood
090981 -                    Test   Infusion
090982 -
090983 -          In.......          0820
090984 -          Out......          1120
090985 -          Visit....      Min  3.0  Hours  Total 2.5 Hours reported
090987 -      ..
090988 -     Pain Assessment...
090989 -
090990 -          x
090991 -          0123456789 10
090992 -
090993 -     <923k
090994 -     Administration Site:  Right Port Catheter
090995 -     Needle Size:          20 G 1"
090996 -     Blood Return Good:    Yes
090998 -      ..
090999 -     Remind patient to call MD if temp > 101 F, Shaking Chills
091000 -
091001 -            This protocol differs from Kaiser requirements, reported on
091002 -            041202. ref SDS 11 IX9N
091003 -
091004 -
091005 -
091006 -
0911 -

SUBJECTS
Side Effects Infusion Clinic UCSF Consultation Treatment Cetuximab A

3403 -
3404 - 0940
340501 -  ..
340502 - Side Effects Minimal...
340503 -
340504 - Follow up ref SDS 76 QU8K, ref SDS 73 QU8K.
340506 -  ..
340507 - Nurse's notes report side effects...
340509 -             ..
340510 -        1.  Rash acne-like
340511 -
340512 -            Follow up ref SDS 76 958F, ref SDS 73 958F.
340513 -
340514 -            Very mild facial rash barely visible continues the same
340515 -            from 070208 around the nose and chin. ref SDS 40 QU8K
340516 -            Antibiotic treatment effective prescribed on 070222.
340517 -            ref SDS 42 FO66
340518 -
340520 -             ..
340521 -        2.  Dry skin face, chest arm
340522 -
340523 -            Follow up ref SDS 76 JS6M, ref SDS 73 JS6M.
340524 -
340525 -            Background reported on 070503. ref SDS 63 JS6M  Condition
340526 -            continues controlled getting positive results with Curel
340527 -            treatment prescribe on 070301, ref SDS 44 5V73, and later
340528 -            Aquaphor on 070322. ref SDS 53 JS6M
340529 -
340531 -             ..
340532 -        3.  Dizziness Symptoms Enlarged Right Ventricle Cor Pulmonale
340533 -
340534 -            Follow up ref SDS 76 Y14O.
340535 -
340536 -            Recurrance of slight dizziness getting out of bed was
340537 -            reported to the medical team starting last week on 070524.
340538 -            ref SDS 75 PT4K  Dizziness is a symptom of Cor Pulmonale,
340539 -            which Kaiser diagnosed in Millie's case in a CT test report
340540 -            on 060930, and reviewed on 061012. ref SDS 27 LG9L  On
340541 -            070525 dizziness recurrence was presented to primary care
340542 -            physician at Kaiser. ref SDS 77 PT4K  This seems very mild
340543 -            and even less than last week.  There is no evident
340544 -            connection to cetuximab treatments at UCSF.
340545 -
340547 -             ..
340548 -        4.  Lymphedema Cellulitis Complications None Evident
340549 -            Inflammation Erratic Upper Left Arm Side Effects Cetuximab
340550 -
340551 -            Follow up ref SDS 76 SU6L, ref SDS 73 SU6L.
340552 -
340553 -            Lymphedema continues relatively controlled with swelling in
340554 -            the left arm reduced to near normal today at 10.50, cited
340555 -            in the study on 060509. ref SDS 14 HO7F  There are no
340556 -            evident signs of Cellulitis.
340558 -             ..
340559 -            Changing intensity of rash on the upper left arm seems
340560 -            reduced in recent weeks, reported on 070503, ref SDS 68
340561 -            8B8I, and previously by the medical team on 070426,
340562 -            ref SDS 65 115F, and following the report at Kaiser on
340563 -            070330. ref SDS 58 N19J  Causes of erratic inflammation,
340564 -            including side effects of cetuximab treatments are listed
340565 -            in the record for treatment on 070426. ref SDS 66 8B8Y
340566 -
340568 -             ..
340569 -        5.  Tired, fatigued - pulmonary emoblism
340570 -
340571 -            Follow up ref SDS 76 FG3N, ref SDS 73 FG3N.
340572 -
340573 -            Fatigue, shortness of breath and other symptoms of
340574 -            pulmonary embolism were presented during meeting on 070130,
340575 -            ref SDS 36 CV5L, citing case study listed on 060722.
340576 -            ref SDS 18 ZV41  These are also side effects of cetuximab
340577 -            treatments, reported on 070116. ref SDS 35 O64M  Planning
340578 -            was discussed this morning with the medical team for thin
340579 -            slice spiral CT test to assess pulmonary embolism and Cor
340580 -            Pulmonale (enlarged right ventricle), per above.
340581 -            ref SDS 70 VP4H
340583 -             ..
340584 -            Energy and exercise remain active, reported on 070503.
340585 -            ref SDS 68 CA4K
340587 -             ..
340588 -            Naps continue 2 - 3 hours after treatments, since beginning
340589 -            on 070405. ref SDS 59 BB7G  May indicate accumulating
340590 -            effects of cetuximab that make patients tired, listed as
340591 -            side effect in Consent documents reviewed on 070116.
340592 -            ref SDS 35 O64M
340593 -
340595 -             ..
340596 -        6.  Heavy chest - shortness of breathing
340597 -
340598 -            Follow up ref SDS 76 UL6L, ref SDS 73 UL6L.
340599 -
340600 -            Patient history was reported to UCSF on 070130. ref SDS 36
340601 -            RT6I
340603 -             ..
340604 -            Condition seems improved, tracking continuing higher
340605 -            energy, per above. ref SDS 0 CA4K
340606 -
340608 -             ..
340609 -        7.  Cough - clearing throat
340610 -
340611 -            Follow up ref SDS 76 8N4G, ref SDS 73 8N4G.
340612 -
340613 -            Condition seems less evident lately.
340614 -
340615 -
340616 -
340617 -
3407 -

SUBJECTS
Schedule Treatment Weekly Thursday 0830 4 Week Cycles Clinical Study

4203 -
420401 -  ..
420402 - Schedule Weekly Treatments Continue on Thursdays
420403 -
420404 - Follow up ref SDS 76 QK6L, ref SDS 73 QK6L.
420405 -
420406 - Millie's next treatment is scheduled for 070607 0830, after meeting
420407 - with the medical team at 0800, as reported by Nola on 070510.
420408 - ref SDS 70 3E8L
420409 -
420410 -
4205 -

SUBJECTS
Port Catheter IV Connection Prepare for Drip Treatment 1 Try Require

5803 -
5804 - 0845
580501 -  ..
580502 - Preparation for Treatment Required One (1) Attempt to Connect Port
580503 -
580504 - Follow up ref SDS 76 EB7J, ref SDS 73 EB7J.
580506 -  ..
580507 - The nurse connected the IV tubes to the port....
580509 -       ..
580510 -      Interlink System Vented Paclitaxel set
580511 -
580513 -  ..
580514 - Blood Draw Flow Sluggish from Port Catheter
580515 -
580516 - There was a problem today getting blood to flow from the port
580517 - catheter, unlike last week and earlier on 070301, when blood flow from
580518 - the port was normal, ref SDS 46 EB7J  Difficult blood flow from the
580519 - port occurred previously on 070222, ref SDS 42 DC5W, and earlier on
580520 - 070201. ref SDS 37 DC5W
580522 -  ..
580523 - Catherine advised that when problems drawing blood from a port
580524 - catheter occur, patients are sent to a work station on the 1st floor,
580525 - possibly the Lab, where some kind of maintenance is performed to
580526 - restore normal flow and functioning of the port.
580528 -  ..
580529 - Millie's case is may require coordination with Kaiser where the port
580530 - was installed on 040419. ref SDS 4 0001
580532 -  ..
580533 - The nurse flushed the port with saline.
580534 -
580535 -
580536 -
5806 -

SUBJECTS
Benadryl Pre-treatment Prepares Patient for Cetuximab Chemotherapy A

6703 -
6704 - 0835
670501 -  ..
670502 - Benadryl Reduce Side Effects Cetuximab Chemotherapy Treatment
670503 -
670504 - Follow up ref SDS 76 DC7J, ref SDS 73 DC7J.
670505 -
670506 - Benadryl (diphenhydramine) started.   25 MG....... ref SDS 66 IJ44
670507 -
670508 -        Purpose reported on 060721. ref SDS 16 DC7J
670510 -  ..
670511 - Chemotherpay order calls for Benadryl (diphenhydramine) pre-treatment
670512 - 30 - 60 minutes prior to cetuximab infusion, shown below. ref SDS 70
670513 - IJ41
670514 -
670515 -
670517 -  ..
6706 -
6707 -
6708 - 0905
6709 -
670901 - Benedryl completed equipment beeps.
670902 -
670903 -
670904 -
670906 -  ..
6710 -
6711 -
6712 -
6713 -
671301 - Decadron (dexamethasone) IV pre-treatment........ ref SDS 53 FM4M
671302 -
671303 - On 070208 Decadron was not given because Millie did not experience
671304 - side effects of nausea and vomitting after treatment with cetuximab on
671305 - 070201. ref SDS 40 G57I  Since this favorable condition continues, per
671306 - above, ref SDS 53 D19M, Decadron was not given again today.
671307 -
671309 -  ..
6714 -
6715 -
6716 -
671601 - Decadron completed -- not reported.
671602 -
671603 -
671604 -
671605 -
6717 -

SUBJECTS
Buck Millie Meeting Patient Catherine Mitsuoka Nurse Infusion Clinic

7903 -
7904 - 0915
790501 -  ..
790502 - Cetuximab Full Dose Blood Counts Below Targets Treatment 1 Hour
790503 -
790504 - Follow up ref SDS 76 4N5M, ref SDS 73 4N5M.
790506 -  ..
790507 - Cetuximab started.
790508 -
790509 -           Verify chemotherapy order for 070208.
790511 -  ..
790512 - Chemotherapy order calls for cetuximab to start 30 - 60 minutes after
790513 - Beyadryl pre-tretment. ref SDS 0 IJ41
790515 -  ..
790516 - Chemotherapy Orders...
790517 -
790523 -    Auth#                                     Stor BCC LOC
790524 -    Visit:  12575738             DOS 20070201
790526 -     ..
790527 -    Date:  20070201
790529 -     ..
790530 -    Study Order for CC#05752:  Phase II Trial of Cetuximab alone and
790531 -    in combination with Carboplatin in ER-negative, PR-negative,
790532 -    HER2-negative Nonoverexpressing Metastatic Breast Cancers
790534 -     ..
790535 -    Dates to be given:  070201
790536 -    Arm 1:Cetuximab alone
790538 -     ..
790539 -    Diagnosis:  breast cancer
790541 -     ..
790542 -    ICD-9 codes: 174.9
790543 -    Allergies  NKDA
790545 -     ..
790546 -    Pre-medications 30 - 60 minutes prior to cetuximab infusion
790548 -     ..
790549 -    4. Diphenhydramine 25 mg IV or  [illegible writing]
790550 -
790551 -       Benadryl........... ref SDS 53 DC7J
790552 -
790553 -       On 070329 Brigid changed the Chemotherapy Order reducing
790554 -       Diphenhydramine (Benadryl) from 50 mg to 25 mg in order to
790555 -       reduce side effects of "restless legs." ref SDS 56 IJ44
790557 -        ..
790558 -       This was effective, reported above. ref SDS 56 7R6H
790560 -     ..
790561 -    5. Dexamethasone (??) 10 mg IB or 20 mg IV [handwritten ???]
790562 -
790563 -       Further premed TBD [barely legible handwriting??]
790565 -     ..
790566 -    Medication:  (plan to give weekly ********STUDY SUPPLY**********
790568 -     ..
790569 -    6. Cetuximab (Erbitux) (loading dose)
790570 -
790571 -              400 mg/m [squared] = 684 mg IV over 120 minutes for
790572 -              first dose x 1
790573 -
790574 -       dose on dcte 20070201   Maximum infusion rate is 5 ml/minute
790575 -       (concentration 2 mg/ml)
790577 -     ..
790578 -    7. Cetuximab (Erbitux) (maintenance dose)
790579 -
790580 -              250 mg/m [squared] = 428 mg IV (or ____ mg/m[squared] =
790581 -              ____mg) IV over 60 or ____ minutes.
790582 -
790583 -       Maximum infusion rate is 5 ml/minute (concentration 2 mg/ml)
790584 -       Infuse once weekly for 8 weeks.  First dose to be given on date
790585 -       20070201.
790587 -        ..
790588 -       Cetuximab is administered undiluted through a low protien
790589 -       binding 0.22 micro in-line filter.  Use NS solution to flush the
790590 -       line at the end of the infusion.
790592 -        ..
790593 -       ARM 2:  Administer carboplatin of vital signs are unremarkable
790594 -       one hour after cetuximab infusion.
790596 -        ..
790597 -       Vital signs at baseline, upon cetuximab completion and one hour
790598 -       after cetuximab.
790599 -
790600 -       ****please note start and stop times****
790602 -        ..
790603 -       Laboratory work:
790604 -
790605 -          See carboplatin orders
790607 -        ..
790608 -       x  Notify MD for dose modifications if patient has severe
790609 -          acne in form rash
790610 -
790611 -          CBC with differential and platletes every 4 weeks
790612 -          Creatinine and magnesium every 4 weeks
790613 -          BUN AST Alk phos Alt Total bilrubin, electrolyes every 8
790614 -          weeks.  If levels are outside of normal laboratory values
790615 -          notify Brigid NP  (MD/RN) at 415 443 4730
790617 -        ..
790618 -       x  Physician has discussed risks/benefits of therapy with the
790619 -          patient.  Signed consent obtained.
790620 -
790621 -
790622 -          Yes   5.  O2 by nasal cannula at 2 liters/min prn for chest
790623 -          pain or SOB
790625 -           ..
790626 -          Yes   6.  Diphenhydramine 50 mg IV prn x1 for urticaria
790627 -          [barely legible], pruritis SOB
790629 -           ..
790630 -          Yes   7.  Hydrocortizone 100 mg IV prn x1 for urticaria
790631 -          [barely legible], pruritis SOB
790633 -           ..
790634 -          Yes   8.  Albuterol inhaler 2-4 puffs prn SOB or chest
790635 -          tightness
790637 -           ..
790638 -          Yes   9.  Epinephrine 1x1000 (1 mg/ml) 0.3 mg IV prn
790639 -          anaphylaxis
790641 -           ..
790642 -          Breast CC05752 Cetuximab doc 20061024
790643 -          Approved 20060615
790645 -           ..
790646 -          Physician signature [Hope Rugo]
790648 -           ..
790649 -          Provider#  35313
790651 -           ..
790652 -          Date:  20010131
790653 -
790655 -  ..
7907 -
7908 -
7909 - 1015
7910 -
791001 - Cetuximab treatment completed.
791002 -
791003 - Millie had a 1 hour rest and observation period, required by the
791004 - protocol. ref SDS 70 G679
791005 -
791006 -
791007 -
791009 -  ..
7911 -
7912 -
7913 - 1120
7914 -
791401 - Nurse disconnected the IV tubes.
791403 -  ..
791404 - She inserted Herceptin to flush the port.
791406 -  ..
791407 - She then removed the needle from the port, and swabbed the needle
791408 - wound, and placed a temporary bandage.
791409 -
791410 -
791411 -
791412 -
791413 -
7915 -

SUBJECTS
Vitals Blood Pressure Pulse Temperature Sa02 Weight Infusion Treatme

8803 -
8804 - 0830
880501 -  ..
880502 - Vitals Show Patient Stable
880503 -
880504 - Follow up ref SDS 76 AW4L, ref SDS 73 AW4L.
880505 -
880506 -     Conversion Celsius to Farhenheit...
880507 -
880508 -              http://www.wbuf.noaa.gov/tempfc.htm
880509 -
880510 -                     Blood
880511 -    Date   Time   Pressure  Pulse  Temperture  Weight So2
880512 -    .
880513 -    070531 1120..... 133  81     70   36.3c  97.34          98
880514 -    070531 1015..... 139  81     59   36.4c  97.52          98
880515 -    070531 0830..... 144  79     60   35.9c  96.62         100
880516 -    070524 1235..... 134  75     61   36.6c  97.88          99
880517 -    070524 1145..... 119  69     58   37.1c  98.78          98
880518 -    070524   standing..........  67 ................
880519 -    070524 0945..... 132  80     56   37.0c  98.60          98
880520 -    070517 1120..... 126  72     56   36.7c  98.06         100
880521 -    070517 1020..... 140  75     54   36.6c  97.88          98
880522 -    070517 0940..... 140  75     54   36.1c  96.98          99
880523 -    070510 1145..... 145  86     54   35.9c  96.62         100
880524 -    070510 1045..... 149  82     69   37.0c  98.60          97
880525 -    070510 0900..... 132  75     62   36.8c  98.24          99
880526 -    070503 1150..... 113  67     59   36.8c  98.24          98
880527 -    070503 1055..... 125  72     54   36.1c  96.98         100
880528 -    070503 0915..... 127  70     60   36.9c  98.42          99
880529 -    070426 1130..... 119  70     57   36.3c  97.34          96
880530 -    070426 1030..... 141  73     67   36.4c  97.52          99
880531 -    070426 0900..... 130  78     52   36.5c  97.7           97
880532 -
880533 -
880534 -
880535 -
8806 -

SUBJECTS
Energy Normal Stable Alert Drive Home After Treatment Tired Sleep 2

A403 -
A404 - 1120
A40501 -  ..
A40502 - Energy Normal Stable After Treatment Cetuximab Support Drugs
A40503 -
A40504 - Follow up ref SDS 76 F54N, ref SDS 73 F54N.
A40506 -  ..
A40507 - On 060724 diary side effects for cetuximab chemotherapy treatment on
A40508 - clinical study drug trial. ref SDS 18 YP4I
A40510 -  ..
A40511 - Millie was alert after treatment again today, and not wobbly nor
A40512 - disoriented.  She was able to drive home without side effects of
A40513 - treatment.
A40515 -  ..
A40516 - After arriving home about 1210, Millie took a nap from about 1420
A40517 - until about 1530.  Could relate to side effects from cetuximab
A40518 - treatments that cause fatigue, reported on 070116. ref SDS 35 O64M
A40519 -
A40520 -
A40521 -
A40522 -
A40523 -
A40524 -
A40525 -
A406 -