PROTOCOL THS 94-002 
REVISED 5/19/94 
PAGE 10 
Level 0 represents the starting dose in all patients. Chemotherapy will be repeated every 30 days provided 
patient has recovered from all toxicities and lab work has normalized (absolute granulocyte count 
^1,800/mm^, platelet count 00, 000/mm^, and creatinine _< 1.5 mg/dl). Cisplatin will not be given if grade 
IV neutropenia develops at level -2. 
Cisplatin; Will be diluted in 500 cc NS + 8 meq MgS 04 and administered IV over 2 hours daily on 
days 1-3. Hydration with 500 cc of D5W+1/2 NS + 8 meq MgS04 given over 3 hours pre- and 
post-cisplatin infusion. 
/Vll patients should be receive appropriate antiemetics. 
5.12.1 Cisplatin dosage changes for the subsequent course shall be based on the 
myelosuppression and other toxicity encountered in the preceding course. The dose 
modification will be as follows: 
5.12.1.1 
Lowest Absolute 
Granulocvte count 
Lowest platelet count 
Next Course 
Cisolatin 
^500 
and 
^50,000 
No change 
<500 
or 
<50,000 
-1 dose 
neutropenic fever 
or 
bleeding 
-1 dose 
5.12.1.2 
Non-hematolooic toxicity 
grade 3 
grade 4 
Creatinine must be ^1.5 mg/dl before resuming chemotherapy. 
6.0 PRE-TREATMENT EVALUATION 
6.1 A complete history and physical to include performance status, recent weight loss, usual weight and 
concurrent non-malignant disease and its therapy, and all prior anticancer treatments must be 
recorded. 
6.2 Laboratory studies shall include quantitative immunoglobulins; a CBC with differential and platelet 
count; SMA-12 and electrolytes, including creatinine, bilirubin, SGPT, alkaline phosphatase, 
urinalysis, and chest x-ray. 
6.3 Any residual toxicity from prior therapies should be recorded using the grading schema in Appendix 
C. 
6.4 Appropriate studies should be obtained to fully define the extent and severity of existing or 
suspected malignant and non-malignant disease. 
6.5 Measurements of disease that can be measured on the chest roentgenogram will be documented. 
The location and size of the endobronchial lesion must be recorded prior to treatment. A 
photograph of the area will be taken at a fixed distance from the lesion. The area will be measured 
in 2 dimensions (product of longest and perpendicular dimensions). 
6.6 A pretreatment blood sample will be collected and stored for analysis of leukocytes and serum. 
-I level 
discontinue cisplatin 
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