Participant flow

Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2014-05-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

   id

   FG000

   title

   Arm I (Bortezomib+Irinotecan)

2. description

   Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).

   id

   FG001

   title

   Arm II (Bortezomib)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      alternative therapy

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      other (reasons were not specified)

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      type

      ineligible/no protocol therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         44

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         41

      type

      Eligible

   3. achievements

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         41

      type

      Treated

   4. achievements

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         38

      type

      Eligible and Treated

   5. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. comment

         11 patients who progressed on bortezomib crossed over to Arm I. 10 of them were eligible

         group Id

         FG001

         num Subjects

         11

      type

      Cross Over to the Other Arm

   6. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         10

      type

      Eligible Patients Who Cross Over

   7. achievements

      1. comment

         Treatment continued until disease progression or intolerable toxicity.

         group Id

         FG000

         num Subjects

         15

      2. comment

         Treatment continued until disease progression or intolerable toxicity.This number is for stage I.

         group Id

         FG001

         num Subjects

         32

      type

      COMPLETED

   8. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         12

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

E1304 was open to accrual on July 20, 2005 and was suspended on September 29, 2006. The trial was reactivated on October 18, 2006 with dose reduction for irinotecan. Arm I was closed with 27 patients after stage I. Arm B proceeded to the second stage of accrual without suspension and closed on September 24, 2008 after enrolling 44 patients.

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Preserved source evidence · Not medical advice