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A Phase I Study of Cantuzumab Mertansine Administered as a Single Intravenous Infusion Once Weekly in Patients with Advanced Solid Tumors

Paul R. Helft, Richard L. Schilsky, Frank J. Hoke, Daphne Williams, Hedy L. Kindler, Evie Sprague, Mark DeWitte, Helen K. Martino, John Erickson, Lini Pandite, Mark Russo, John M. Lambert, Maria Howard and Mark J. Ratain
Paul R. Helft
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Richard L. Schilsky
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Frank J. Hoke
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Daphne Williams
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Hedy L. Kindler
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Evie Sprague
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Mark DeWitte
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Helen K. Martino
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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John Erickson
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Lini Pandite
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Mark Russo
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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John M. Lambert
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Maria Howard
University of Chicago, Chicago, Illinois; ImmunoGen, Cambridge, Massachusetts; and Glaxo SmithKline, Collegeville, Pennsylvania
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Mark J. Ratain
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DOI: 10.1158/1078-0432.CCR-04-0088 Published July 2004
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    Fig. 1.

    Trough plasma concentration versus number of doses (or weeks of treatment) for a single patient treated at 96 mg/m2. Drug accumulation is demonstrated by increasing serum trough concentrations of cantuzumab mertansine over time for 1 patient treated for ∼1 year.

Tables

  • Figures
  • Table 1

    Patient characteristics

    CharacteristicNo. of patients
    No. of patients39
    Sex
     Male24
     Female15
    Age, years
     Median61
     Range36–81
    ECOGa performance status
     014
     124
     21
    Prior therapy
     None2
     Chemotherapy only26
     Chemotherapy and radiotherapy10
    Tumor type
     Colon and rectum24
     Pancreas8
     Unknown primary3
     Lung2
     Gastric1
     Peritoneum1
    • a ECOG, Eastern Cooperative Oncology Group.

  • Table 2

    Doses administered

    Dose (mg/m2/week)No. of patientsTotal no. of doses administered
    4016
    6016
    80316
    96496
    11523134
    138722
  • Table 3

    Summary of toxicities greater than grade 1 in the 21-day determinative period

    Dose level (mg/m2)No. of patientsNo. of patients with DLTaElevated AST/ALTElevated alkaline phosphataseElevated total bilirubinElevated amylase/lipaseAnemiaFatigueNauseaDiarrhea
    Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3
    401
    601
    803
    9641
    1152317511112311
    1387313b221b
    • a DLT, dose-limiting toxicity; AST, aspartate aminotransferase; ALT, alanine aminotransferase.

    • b This event constituted a DLT.

  • Table 4

    Pharmacokinetic parameters

    Dose (mg/m2)nAUClast (mg·h/liter)aCmax (mg/liter)Vd (liter)t1/2 (h)AUClast/dose (h/ml)
    40121610.75.35133.6
    60192734.04.04228.1
    8031582 (338)43.5 (1.2)5.53 (1.54)39 (2)10.2 (2.9)
    9631987 (553)51.2 (5.8)4.85 (0.77)37 (9)10.8 (3.3)
    11552650 (999)73.5 (17.3)4.06 (1.02)40 (19)11.7 (4.2)
    13853463 (1131)80.8 (20.8)4.58 (0.96)41 (9)12.8 (5.0)
    • a AUClast, area under the plasma concentration-time curve from the time of dosing to the last observable concentration; Cmax, maximum observed plasma concentration; Vd, volume of distribution; t1/2, terminal half-life.

  • Table 5

    Tumor CanAg expression

    Tumor stainingaHomogeneousHeterogeneousHomogeneous/HeterogeneousFocal
    1+1
    2+32
    3+18626
    • a One patient was CanAg negative.

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Clinical Cancer Research: 10 (13)
July 2004
Volume 10, Issue 13
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A Phase I Study of Cantuzumab Mertansine Administered as a Single Intravenous Infusion Once Weekly in Patients with Advanced Solid Tumors
Paul R. Helft, Richard L. Schilsky, Frank J. Hoke, Daphne Williams, Hedy L. Kindler, Evie Sprague, Mark DeWitte, Helen K. Martino, John Erickson, Lini Pandite, Mark Russo, John M. Lambert, Maria Howard and Mark J. Ratain
Clin Cancer Res July 1 2004 (10) (13) 4363-4368; DOI: 10.1158/1078-0432.CCR-04-0088

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A Phase I Study of Cantuzumab Mertansine Administered as a Single Intravenous Infusion Once Weekly in Patients with Advanced Solid Tumors
Paul R. Helft, Richard L. Schilsky, Frank J. Hoke, Daphne Williams, Hedy L. Kindler, Evie Sprague, Mark DeWitte, Helen K. Martino, John Erickson, Lini Pandite, Mark Russo, John M. Lambert, Maria Howard and Mark J. Ratain
Clin Cancer Res July 1 2004 (10) (13) 4363-4368; DOI: 10.1158/1078-0432.CCR-04-0088
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