Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Five-hundred and two (502) participants were recruited between February 2006 and December 2008 at Mayo Clinic Cancer Research Consortium (MCCRC) sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eight patients canceled before the first dose of darbepoetin alfa (DA) (3 DA + Intravenously (IV) Iron, 3 DA + Oral Iron and 2 DA + Placebo); and 4 patients were ineligible (2 DA + Oral Iron, 2 DA + Placebo). These 12 patients were excluded from all analysis.

Reporting Groups

	Description
DA + IV Iron	Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
DA + Oral Iron	Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
DA + Placebo	Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

Participant Flow:   Overall Study

	DA + IV Iron	DA + Oral Iron	DA + Placebo
STARTED	164	163	163
COMPLETED	105	113	106
NOT COMPLETED	59	50	57
Adverse Event	11	5	8
Death	8	6	3
Other Reasons	5	12	23
Withdrawal by Subject	30	23	14
Alternative Treatment	1	0	0
Other Medical Problems	4	4	9

Reporting Groups

	Description
DA + IV Iron	Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
DA + Oral Iron	Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
DA + Placebo	Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

Baseline Measures

	DA + IV Iron	DA + Oral Iron	DA + Placebo	Total
Number of Participants   [units: participants]	164	163	163	490
Age   [units: years] Mean ± Standard Deviation	64  ± 11	63  ± 13	63  ± 11	63  ± 12
Gender   [units: participants]
Female	109	106	105	320
Male	55	57	58	170
Race (NIH/OMB)   [units: Participants]
American Indian or Alaska Native	0	3	1	4
Asian	0	3	1	4
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	6	7	4	17
White	155	147	156	458
More than one race	0	0	0	0
Unknown or Not Reported	3	3	1	7
Degree of Anemia   [units: Participants]
Mild: Hemoglobin>=9.5	123	123	123	369
Severe: Hemoglobin <9.5	41	40	40	121
Platinum-Containing Regimen   [units: Participants]
Yes	79	79	78	236
No	85	84	85	254
Tumor Type   [units: Participants]
Hematologic Neoplasm	6	8	11	25
Solid Tumor	157	154	151	462
Both	1	1	1	3
Weight   [units: kg] Mean ± Standard Deviation	77.4  ± 18.74	79.4  ± 19.75	76.4  ± 17.68	77.7  ± 18.75
Height   [units: cm] Mean ± Standard Deviation	166.9  ± 9.44	167.7  ± 8.93	166.8  ± 9.36	167.1  ± 9.24
Baseline Ferritin   [units: µg/L] Mean ± Standard Deviation	460.5  ± 526.99	479.5  ± 484.15	456.0  ± 479.27	465.3  ± 496.41
Baseline Transferrin Saturation   [units: Percentage Saturation] Mean ± Standard Deviation	22.5  ± 12.81	19.6  ± 11.7	22.2  ± 13.36	21.5  ± 12.69

1.  Primary:

Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response   [ Time Frame: 16 Weeks ]

2.  Secondary:

Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL   [ Time Frame: 16 Weeks ]

3.  Secondary:

Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions   [ Time Frame: Week 1 to Week 16 ]

4.  Secondary:

Mean Increment in Hemoglobin Level at Week 7   [ Time Frame: Baseline and 7 weeks ]

5.  Secondary:

Mean Increment in Hemoglobin Level at Week 16   [ Time Frame: Baseline and 16 weeks ]

6.  Secondary:

Time to Hematopoietic Response   [ Time Frame: 16 weeks ]

7.  Secondary:

Time to First Red Blood Cell (RBC) Transfusions   [ Time Frame: 16 weeks ]

8.  Secondary:

Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)   [ Time Frame: Baseline and 16 weeks ]

9.  Secondary:

Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study   [ Time Frame: Baseline and 16 weeks ]

10.  Secondary:

Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study   [ Time Frame: Baseline and 16 weeks ]

11.  Secondary:

Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study   [ Time Frame: Baseline and 16 weeks ]

12.  Secondary:

C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16   [ Time Frame: 1 Week, 7 Weeks and 16 Weeks ]

13.  Secondary:

Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16   [ Time Frame: 1 week, 7 weeks and 16 weeks ]

14.  Secondary:

Ferritin Level at Baseline, Week 7 and Week 16   [ Time Frame: Baseline, 7 weeks and 16 weeks ]

15.  Secondary:

Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16   [ Time Frame: Baseline, 7 weeks and 16 weeks ]

16.  Secondary:

Transferrin Saturation at Baseline, Week 7 and Week 16   [ Time Frame: Baseline, 7 weeks and 16 weeks ]