Table 3

Non-neurological toxicity

Dose (mg/m2)Clinical signsLaboratoryRemarks
FVCOtherEosinophiliaALTaASTaCKa
Grade
0.06Dischargedb
0.06+DPc
0.12121DP
0.12Sialorrhea, IBPd121DP
0.18221DP
0.18Diarrhea, IBP221SDe A.T.f
0.21 Embedded Image 221CRg
0.22+221SD A.T.f
0.22+221PRh
0.22Sialorrhea+221DP
0.21221PR
0.21+221DP
0.21+121PR
0.21Diarrhea, IBP, Anaphylaxis221Dischargedb
0.21IBP121A.T.h
  • a The increases in ALT, AST, and CK listed are observed during the first 2 weeks of treatment. They decrease during the third week and return to normal during the fourth week of treatment.

  • b Patient was removed from protocol on study day 6 because of biliary obstruction and required surgery. Another patient presented grade 3 anaphilaxis on study day 31.

  • c DP, disease progression.

  • d Grade 1 increase in blood pressure.

  • e SD, stable disease. Three patients abandoned the treatment after the first 30-day cycle, unable to continue with the obligatory in-patient condition required for this study.

  • f A.T., abandoned treatment.

  • g CR, complete response.

  • h PR, measurable partial response.