|
4.0
|
Tests
and procedures
|
7 days prior to registration
|
Weekly x 4 for first month
|
Monthly
while receiving study medication
4
|
|
History and exam, weight,
PS
|
X
|
.
|
X
|
| Weight
(Appendix
II) |
.
|
X
|
X
|
|
Patient
completed QOL FAACT (Appendix III)
|
X
|
X
|
X
|
| Patient
Questionnaire (Appendix
I) |
|
X
|
X
|
Albumin
|
X
(optional)
|
.
|
|
Serum
pregnancy test2
|
X
|
.
|
|
IL-6
levels5
|
X
|
.
|
|
1.
Every two months after the first month.
2. For women of childbearing potential only.
3. Note that questions 9 -16 cannot be answered prior
to study treatment.
4.
The study medication has been packaged as a 30-day supply;
therefore, it will be necessary to call the Randomization
Center monthly to obtain new treatment bottle numbers.
5. Research test, no patient change, 5 ml of serum
stored at -70°C. Under extenuating circumstances, patient
enrollment in the translational component may be waived
by calling the NCCTG Operations Office. See Section
14 and Appendix V (Serum Specimen Logistics - not available
Online).
6. At one month only.
|