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Table 2 Detailed overview of the treatment protocol

From: A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer

Cycle

0

1

2

3

4

5

6

7

day

 

1

8

15

22

29

36

43

50

57

64

71

78

85

92

99

106

113

120

127

134

141

history

X

                     

eligibility criteria

X

                     

informed consent

X

                     

Trastuzumab i.v.

 

X1

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Capecitabine p.o.

 

1–14

 

22–35

 

43–58

 

64–77

 

85–98

 

106–119

 

127–140

 

vital signs, physical exam2

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

analgesic consumption3

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

pain assessment3

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

quality of life4

X

      

X

     

X

     

X

  

diagnostic/remission5

X

      

X

     

X

     

X

  

CA 19-9 level6

X

X*

  

X

  

X

  

X

  

X

  

X

  

X

  

hematology7

X

X#

X§

X§

X

X§

X§

X

X§

X§

X

X§

X§

X

X§

X§

X

X§

X§

X

X§

X§

blood chemistry8

X

X

  

X

  

X

  

X

  

X

  

X

  

X

  

toxicity (NCI CTC 3.0)9

X

   

X

  

X

  

X

  

X

  

X

  

X

  

ECG

X

            

X

        

TEE

X

            

X

        
  1. 1. Trastuzumab: initial dose 4 mg/kg body weight, subsequent cycles 2 mg/kg body weight
  2. 2. vitals signs and physical exam: height, weight, Karnofsky performance status, pulse rate, blood pressure, temperature
  3. 3. analgesic consumption and pain symptoms (visual analogue scale)
  4. 4. EORTC QLQ-C30 (v3.0) questionnaire
  5. 5. tumor diagnostic: imaging study, HER2/neu analysis; status of remission for at least 12 weeks: CT- or MRI Abdomen, CXR (CT-chest)
  6. 6. CA19-9: serum level (ELSIA), * no measurement if between time point 0 and 1st day of cycle 1 < 4 weeks
  7. 7. Hematology: complete blood count (CBC), differential blood count; # no measurement if between time point 0 and 1st day of cycle 1 < 1 weeks; §only CBC
  8. 8. Blood chemistry: total bilirubin, ALT, AST, alk. Phos., γ-GT, total protein, albumin, creatinine, uric acid, sodium, potassium, calcium
  9. 9. NCI: CTC vers. 3.0. If toxicity > 2 reevaluation by study physical
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