Trials / Terminated

TerminatedNCT00096148

Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Randomized Phase II Trial of Idarubicin + Ara-C +/- Bevacizumab in Patients Age < 60 With Untreated Acute Myeloid Leukemia

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 120 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 59 Years
Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Bevacizumab may stop the growth of cancer by stopping blood flow to the leukemic cells in the bone marrow. Giving idarubicin and cytarabine with bevacizumab may kill more cancer cells. It is not yet know whether giving idarubicin together with cytarabine is more effective with or without bevacizumab in treating acute myeloid leukemia. This randomized phase II trial is studying how well giving idarubicin and cytarabine together with bevacizumab works compared to idarubicin and cytarabine alone in treating patients with newly diagnosed acute myeloid leukemia

Detailed description

PRIMARY OBJECTIVES: I. Compare the activity of idarubicin and cytarabine with or without bevacizumab in patients with newly diagnosed acute myeloid leukemia. II. Compare the proportion of patients who survive and remain in first complete remission (CR) one year from achieving CR after treatment with these regimens. SECONDARY OBJECTIVES: I. Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (\< 45 vs 45 to 59), cytogenetics (normal vs -5/-7 vs other), flt 3 status (normal vs mutated), and type of acute myeloid leukemia (AML) (de novo vs secondary \[arising after cytotoxic therapy or after an antecedent hematologic disorder, defined as a documented abnormality in blood count for \>= 3 months before diagnosis of AML\]. Patients who require treatment before cytogenetics or flt 3 status is known (e.g., patients with WBC \> 50,000 OR with organ dysfunction thought to be due to blast infiltration) are stratified only according to age and type of AML. Induction therapy: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive idarubicin IV over 1 hour on days 1-3 and cytarabine IV continuously over 24 hours on days 1-4. Arm II: Patients receive idarubicin and cytarabine as in arm I. Patients also receive bevacizumab\* IV over 30-90 minutes on day 1. Patients who do not achieve complete remission (CR) after the first induction course may receive a second induction course approximately 28 days\* later. Patients who do not achieve CR after 2 courses are removed from the study. NOTE: \*Patients in arm II receive bevacizumab, independently of chemotherapy administration schedule, once every 21 days for 1 year from CR date. Post-CR therapy: All patients receive 4 post-CR chemotherapy courses approximately every 28 days in the absence of disease progression or unacceptable toxicity. Course 1: Patients receive cytarabine IV continuously over 24 hours on days 1-5. Course 2 and 4: Patients receive idarubicin IV over 1 hour and cytarabine IV continuously over 24 hours on days 1-4. Course 3: Patients receive idarubicin IV over 1 hour and cytarabine IV continuously over 24 hours on days 1-2. After completion of the 4 post-CR chemotherapy courses, patients in arm I induction therapy do not receive further therapy. Patients in arm II induction therapy continue to receive bevacizumab as described above.After completion of study treatment, patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 60-120 patients (30-60 per treatment arm) will be accrued for this study within 12-30 months.

Conditions

Interventions

Type	Name	Description
DRUG	idarubicin	Given IV
DRUG	cytarabine	Given IV
BIOLOGICAL	bevacizumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

Start date: 2004-10-01
Primary completion: 2006-11-01
First posted: 2004-11-09
Last updated: 2013-01-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00096148. Inclusion in this directory is not an endorsement.