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S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
| Tracking Information | ||||
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| First Received Date ICMJE | January 28, 2000 | |||
| Last Updated Date | March 5, 2015 | |||
| Start Date ICMJE | February 2000 | |||
| Primary Completion Date | May 2001 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
response [ Time Frame: after induction therapy is completed ] | |||
| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | Complete list of historical versions of study NCT00004217 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia | |||
| Official Title ICMJE | A Phase II Study of Daunomycin and ARA-C Given by Continuous IV Infusion With PSC-833 for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older | |||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 2 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Leukemia | |||
| Intervention ICMJE |
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| Study Arms | Not Provided | |||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 55 | |||
| Completion Date | March 2006 | |||
| Primary Completion Date | May 2001 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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 |
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| Ages | 56 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00004217 | |||
| Other Study ID Numbers ICMJE | S9918 S9918 ( Other Identifier: SWOG ) U10CA032102 ( US NIH Grant/Contract Award Number ) |
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| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Southwest Oncology Group | |||
| Study Sponsor ICMJE | Southwest Oncology Group | |||
| Collaborators ICMJE | National Cancer Institute (NCI) | |||
| Investigators ICMJE |
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| PRS Account | Southwest Oncology Group | |||
| Verification Date | March 2015 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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