Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or anemia.

PURPOSE: This randomized phase III trial is studying how well giving zosuquidar trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborators: Eli Lilly and Company; Kanisa Pharmaceuticals; National Cancer Institute (NCI)
• Treatments: Cytarabine; Daunorubicin; Lenograstim; Molgramostim; Sargramostim

Criteria

Inclusion Criteria:

One of the following disorders:

• Acute myeloid leukemia (AML), defined as >30% myeloblasts on the marrow aspirate or peripheral blood differential and any French-American-British (FAB) subtype except M3 (i.e., acute promyelocytic leukemia)

• Refractory anemia with excess blasts (RAEB), defined as 11-20% myeloblasts on bone marrow aspirate or peripheral blood differential, provided there are other criteria for high-risk disease

• Refractory anemia with excess blasts in transformation (RAEB-T), defined as 21-30% myeloblasts on bone marrow aspirate or peripheral blood differential

• Participants may have secondary AML

• Age greater than 60 years

• ECOG performance status of 0 to 3

• Total serum bilirubin < 3 mg/dL

• Serum creatinine < 2 mg/dL

• Cardiac ejection fraction of > 45%

Exclusion Criteria:

• Blastic transformation of chronic myelogenous leukemia

• CNS leukemia

• Prior chemotherapy for AML, with the exception of hydroxyurea

• For women: pregnant or breast feeding

• Other malignancy for which participant is currently receiving treatment

• Concurrent treatment with other colony-stimulating factors