S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by making them more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine in treating older patients who have newly diagnosed acute myeloid leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES: I. Determine the safety and efficacy of daunorubicin and cytarabine by continuous infusion and PSC 833 in patients over age 56 with newly diagnosed acute myeloid leukemia. II. Determine the frequency and severity of toxicities of this regimen in these patients. III. Determine the frequency and prognosis of functional and phenotypic P-glycoprotein expression, cytogenetics, and pharmacokinetics in this population.
OUTLINE: This is a multicenter study. Patients receive induction chemotherapy consisting of PSC 833 IV over 2 hours on day 1, then continuously for 96 hours; daunorubicin IV continuously on days 1-3; and cytarabine IV continuously on days 1-7. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered subcutaneously (SQ) or IV beginning on day 15 and continuing until blood counts recover or day 21. If patients do not achieve complete remission after one course, a second course is administered. Patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status after 1 or 2 courses of induction chemotherapy proceed to consolidation therapy, which begins upon recovery from induction therapy. Consolidation therapy consists of PSC 833 over 2 hours on day 1, daunorubicin IV over 1-5 minutes on days 1 and 2, and cytarabine IV continuously on days 1-5. Treatment repeats for a total of 2 courses. Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 8-9 months.
Study Design
Outcome Measures
Primary Outcome Measures
- response [after induction therapy is completed]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia (AML) No M3 AML or blastic phase chronic myelogenous leukemia Must be registered on protocols SWOG-9007 and SWOG-9910
PATIENT CHARACTERISTICS: Age: 56 and over Performance status: Zubrod 0-3 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT/SGPT no greater than 4 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance greater than 40 mL/min Cardiovascular: LVEF at least 50% by MUGA or echocardiogram No unstable cardiac arrhythmias or angina Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for acute leukemia Prior hydroxyurea to control high cell counts allowed At least 30 days since prior low dose cytarabine (less than 100 mg/m2/day) for myelodysplastic syndrome and recovered Single dose of prior or concurrent (with induction chemotherapy) intrathecal chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MBCCOP - University of South Alabama | Mobile | Alabama | United States | 36688 |
| 2 | CCOP - Greater Phoenix | Phoenix | Arizona | United States | 85006-2726 |
| 3 | Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix | Arizona | United States | 85012 |
| 4 | Veterans Affairs Medical Center - Tucson | Tucson | Arizona | United States | 85723 |
| 5 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
| 6 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 7 | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | United States | 72205 |
| 8 | Veterans Affairs Medical Center - Long Beach | Long Beach | California | United States | 90822 |
| 9 | USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033-0800 |
| 10 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 11 | Beckman Research Institute, City of Hope | Los Angeles | California | United States | 91010 |
| 12 | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | United States | 94553 |
| 13 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
| 14 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 15 | University of California Davis Medical Center | Sacramento | California | United States | 95817 |
| 16 | UCSF Cancer Center and Cancer Research Institute | San Francisco | California | United States | 94115-0128 |
| 17 | Veterans Affairs Medical Center - San Francisco | San Francisco | California | United States | 94121 |
| 18 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
| 19 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
| 20 | Veterans Affairs Medical Center - Denver | Denver | Colorado | United States | 80220 |
| 21 | University of Colorado Cancer Center | Denver | Colorado | United States | 80262 |
| 22 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
| 23 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 24 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 25 | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | United States | 60141 |
| 26 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 27 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
| 28 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
| 29 | Veterans Affairs Medical Center - Wichita | Wichita | Kansas | United States | 67218 |
| 30 | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | United States | 40511-1093 |
| 31 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
| 32 | MBCCOP - LSU Medical Center | New Orleans | Louisiana | United States | 70112 |
| 33 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
| 34 | Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | United States | 70112 |
| 35 | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
| 36 | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | United States | 71130 |
| 37 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 38 | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | United States | 02130 |
| 39 | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | United States | 48105 |
| 40 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0752 |
| 41 | Veterans Affairs Medical Center - Detroit | Detroit | Michigan | United States | 48201-1932 |
| 42 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 43 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 44 | CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | United States | 49503 |
| 45 | Providence Hospital - Southfield | Southfield | Michigan | United States | 48075-9975 |
| 46 | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | United States | 39531-2410 |
| 47 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 48 | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | United States | 39216 |
| 49 | Keesler Medical Center - Keesler AFB | Keesler AFB | Mississippi | United States | 39534-2576 |
| 50 | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | United States | 64128 |
| 51 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 52 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110-0250 |
| 53 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
| 54 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
| 55 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 56 | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | United States | 87108-5138 |
| 57 | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | United States | 87131 |
| 58 | Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | United States | 11209 |
| 59 | Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 60 | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | United States | 45219 |
| 61 | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220-2288 |
| 62 | Cleveland Clinic Cancer Center | Cleveland | Ohio | United States | 44195 |
| 63 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
| 64 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
| 65 | CCOP - Dayton | Kettering | Ohio | United States | 45429 |
| 66 | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | United States | 73104 |
| 67 | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
| 68 | Oregon Cancer Center at Oregon Health Sciences University | Portland | Oregon | United States | 97201-3098 |
| 69 | Veterans Affairs Medical Center - Portland | Portland | Oregon | United States | 97207 |
| 70 | CCOP - Columbia River Program | Portland | Oregon | United States | 97213 |
| 71 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
| 72 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 73 | Veterans Affairs Medical Center - Dallas | Dallas | Texas | United States | 75216 |
| 74 | Simmons Cancer Center - Dallas | Dallas | Texas | United States | 75235-9154 |
| 75 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
| 76 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-1329 |
| 77 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 78 | Texas Tech University Health Science Center | Lubbock | Texas | United States | 79423 |
| 79 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78284-7811 |
| 80 | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | United States | 78284 |
| 81 | Veterans Affairs Medical Center - Temple | Temple | Texas | United States | 76504 |
| 82 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
| 83 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84132 |
| 84 | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | United States | 84148 |
| 85 | CCOP - Southwestern Vermont Regional Cancer Center | Bennington | Vermont | United States | 05201 |
| 86 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
| 87 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
| 88 | Veterans Affairs Medical Center - Seattle | Seattle | Washington | United States | 98108 |
| 89 | CCOP - Northwest | Tacoma | Washington | United States | 98405-0986 |
| 90 | BC Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Thomas R. Chauncey, MD, PhD, VA Puget Sound Health Care System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S9918
- S9918
- U10CA032102