Study: NCT00299182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 50 mg/m\^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 50 mg/m\^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 50 mg/m\^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 50 mg/m\^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Doxorubicin
Description: 50 mg/m\^2/dose by vein over 15 minutes on Day 5 or by continuous infusion over 24-48 hours (days 5-6), Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Dexamethasone
Description: 40 mg/day by mouth or by vein days 2-5 and 12-15, Cycles 1,3,\& 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: 200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: 200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: 200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: 200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: 200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: 200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Methotrexate
Description: 200 mg/m\^2 by vein over 2 hours followed by 800 mg/m\^2 over 22 hours Day 2, Cycles 2, 4 \& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: 3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: 3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: 3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: 3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: 3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: 3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Cytarabine
Description: 3 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4; OR,1 g/m\^2 by vein over 2 hours every 12 hours for 4 doses, days 3 \& 4 for patients \> 60 years and for patients with serum creatinine \> 1.5 mg/dL; Cycles 2,4,\& 6.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Arm A: Placebo - subcutaneous injection administered on days -5 and 5 (pre and post chemotherapy dose) beginning with Cycle 2; OR, Arm B: Placebo - subcutaneous injection administered on days 5 and 7 (post chemotherapy doses only) beginning with Cycle 2.