Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00352365
Collaborator
(none)
41
54
1
61
0.8
0

Study Details

Study Description

Brief Summary

This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Detailed Description

PRIMARY OBJECTIVES:
  1. Test whether the complete response rate among older patients with previously untreated acute myeloid leukemia (AML) with the del (5q) cytogenetic abnormality treated with lenalidomide is sufficiently high to warrant a phase III investigation.

  2. Estimate the frequency and severity of toxicities of this drug in these patients.

  3. Correlate, in a preliminary manner, additional cytogenetic abnormalities with response to lenalidomide.

  4. Estimate the total (complete and partial) response rate and the cytogenetic response rate in these patients.

OUTLINE:

INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy.

MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Lenalidomide (REVLIMID, NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (lenalidomide)

INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy. MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: lenalidomide
Given orally
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
  • Outcome Measures

    Primary Outcome Measures

    1. Complete Response [Up to 5 years]

      Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl.

    Secondary Outcome Measures

    1. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [Up to 5 years]

      Only adverse events that are possibly, probably or definitely related to study drug are reported.

    2. Cytogenetic Abnormalities [Up to 5 years]

      Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.

    3. Total Response [Up to 5 years]

      Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days

    • Diagnostic biopsy within the past 28 days with marrow blast percentage ≥ 70% allowed provided no potentially antileukemic therapy was received after biopsy

    • Cytogenetic evidence of del (5q) abnormality by conventional karyotyping or fluorescence in situ hybridization (FISH)

    • Previously untreated disease

    • Must have declined standard AML cytotoxic chemotherapy regimens

    • WBC ≤ 30,000/mm³

    • History of prior myelodysplastic syndromes (MDS) allowed

    • No acute promyelocytic leukemia (FAB M3)

    • No blastic transformation of chronic myelogenous leukemia

    • Zubrod performance status 0-2

    • Bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)

    • AST and ALT ≤ 3.5 times ULN

    • Creatinine ≤ 1.5 times ULN

    • HIV negative

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use 2 forms of effective contraception at least 4 weeks prior to, during, and for 4 weeks after completion of study treatment

    • No known allergy to thalidomide

    • Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients)

    • No prior systemic chemotherapy for acute leukemia except hydroxyurea

    • Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy

    • No prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support

    • Prior hematopoietic growth factors, thalidomide, arsenic trioxide, signal-transduction inhibitors, azacitidine, and low-dose cytarabine (i.e., < 100 mg/m²/day) for treatment of MDS allowed

    • At least 30 days since prior therapy for MDS (excluding growth factors)

    • No prior lenalidomide for MDS

    • At least 6 months since prior chemotherapy or radiotherapy for another malignancy

    • No concurrent therapy for another malignancy

    • Concurrent hormonal therapy allowed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 Shasta Regional Medical Center Redding California United States 96001
    3 Sutter Roseville Medical Center Roseville California United States 95661
    4 Sutter General Hospital Sacramento California United States 95816
    5 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    6 Cancer Care Center of Decatur Decatur Illinois United States 62526
    7 Decatur Memorial Hospital Decatur Illinois United States 62526
    8 Memorial Medical Center Springfield Illinois United States 62781-0001
    9 Salina Regional Health Center Salina Kansas United States 67401
    10 University of Michigan Ann Arbor Michigan United States 48109
    11 Montana Cancer Consortium CCOP Billings Montana United States 59101
    12 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    13 Saint Vincent Healthcare Billings Montana United States 59101
    14 Hematology-Oncology Centers of the Northern Rockies PC Billings Montana United States 59102
    15 Billings Clinic Billings Montana United States 59107-7000
    16 Deaconess Medical Center Billings Montana United States 59107
    17 Bozeman Deaconess Cancer Center Bozeman Montana United States 59715
    18 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    19 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    20 Berdeaux, Donald MD (UIA Investigator) Great Falls Montana United States 59405
    21 Great Falls Clinic Great Falls Montana United States 59405
    22 Northern Montana Hospital Havre Montana United States 59501
    23 Saint Peter's Community Hospital Helena Montana United States 59601
    24 Glacier Oncology PLLC Kalispell Montana United States 59901
    25 Kalispell Medical Oncology Kalispell Montana United States 59901
    26 Kalispell Regional Medical Center Kalispell Montana United States 59901
    27 Community Medical Hospital Missoula Montana United States 59801
    28 Montana Cancer Specialists Missoula Montana United States 59802
    29 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    30 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    31 Interlakes Foundation Inc-Rochester Rochester New York United States 14623
    32 University of Rochester Rochester New York United States 14642
    33 University of Cincinnati Cincinnati Ohio United States 45267
    34 Cleveland Clinic Cancer Center Independence Independence Ohio United States 44131
    35 Cleveland Clinic Wooster Specialty Center Wooster Ohio United States 44691
    36 University of Tennessee - Knoxville Knoxville Tennessee United States 37920
    37 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    38 Harrison Bremerton Hematology and Oncology Bremerton Washington United States 98310
    39 Columbia Basin Hematology and Oncology PLLC Kennewick Washington United States 99336
    40 Skagit Valley Hospital Mount Vernon Washington United States 98274
    41 Harrison Poulsbo Hematology and Oncology Poulsbo Washington United States 98370
    42 Harborview Medical Center Seattle Washington United States 98104
    43 Minor and James Medical PLLC Seattle Washington United States 98104
    44 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington United States 98109
    45 Group Health Cooperative Seattle Washington United States 98112
    46 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    47 The Polyclinic Seattle Washington United States 98122
    48 University of Washington Medical Center Seattle Washington United States 98195
    49 United General Hospital Sedro-Woolley Washington United States 98284
    50 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
    51 Evergreen Hematology and Oncology PS Spokane Washington United States 99218
    52 Wenatchee Valley Medical Center Wenatchee Washington United States 98801
    53 Rocky Mountain Oncology Casper Wyoming United States 82609
    54 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Mikkael Sekeres, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00352365
    Other Study ID Numbers:
    • NCI-2009-00785
    • NCI-2009-00785
    • SWOG-S0605
    • CDR0000484449
    • S0605
    • S0605
    • U10CA032102
    First Posted:
    Jul 14, 2006
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Jan 1, 2022

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Lenalidomide
    Arm/Group Description Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
    Period Title: Induction Therapy
    STARTED 41
    Eligible 38
    Eligible and Began Protocol Therapy 37
    COMPLETED 14
    NOT COMPLETED 27
    Period Title: Induction Therapy
    STARTED 12
    Eligible and Began Protocol Therapy 8
    COMPLETED 0
    NOT COMPLETED 12

    Baseline Characteristics

    Arm/Group Title Induction Therapy
    Arm/Group Description Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
    Overall Participants 37
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    73.7
    Sex: Female, Male (Count of Participants)
    Female
    21
    56.8%
    Male
    16
    43.2%
    Race/Ethnicity, Customized (participants) [Number]
    Black or African American
    3
    8.1%
    White
    33
    89.2%
    Unknown or Not Reported
    1
    2.7%
    Hispanic (participants) [Number]
    Yes
    1
    2.7%
    No
    32
    86.5%
    Unknown
    4
    10.8%
    Disease Onset (participants) [Number]
    De Novo
    16
    43.2%
    Treatment related
    2
    5.4%
    MDS related
    19
    51.4%
    Performance Status (participants) [Number]
    0
    7
    18.9%
    1
    30
    81.1%

    Outcome Measures

    1. Secondary Outcome
    Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
    Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
    Time Frame Up to 5 years

    Outcome Measure Data

    Analysis Population Description
    Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
    Arm/Group Title Induction Therapy Maintenance Therapy
    Arm/Group Description Oral lenalidomide once daily on days 1-14, 1-21, or 1-28 Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
    Measure Participants 37 8
    ALT, SGPT (serum glutamic pyruvic transaminase)
    1
    2.7%
    0
    NaN
    AST, SGOT
    1
    2.7%
    0
    NaN
    Adult respiratory distress syndrome (ARDS)
    1
    2.7%
    0
    NaN
    Anorexia
    1
    2.7%
    0
    NaN
    Bilirubin (hyperbilirubinemia)
    1
    2.7%
    0
    NaN
    Calcium, serum-low (hypocalcemia)
    3
    8.1%
    0
    NaN
    Cardiac-ischemia/infarction
    1
    2.7%
    0
    NaN
    Cough
    1
    2.7%
    0
    NaN
    Creatinine
    3
    8.1%
    0
    NaN
    Dermatology/Skin-Other (Specify)
    1
    2.7%
    0
    NaN
    Diarrhea
    2
    5.4%
    0
    NaN
    Dyspnea (shortness of breath)
    2
    5.4%
    0
    NaN
    Fatigue (asthenia, lethargy, malaise)
    11
    29.7%
    0
    NaN
    Febrile neutropenia
    15
    40.5%
    2
    NaN
    Glucose, serum-high (hyperglycemia)
    2
    5.4%
    0
    NaN
    Hemoglobin
    7
    18.9%
    2
    NaN
    Induration/fibrosis (skin and subcutaneous tissue)
    0
    0%
    1
    NaN
    Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus
    1
    2.7%
    0
    NaN
    Inf (clin/microbio) w/Gr 3-4 neuts - Lip/perioral
    1
    2.7%
    0
    NaN
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung
    5
    13.5%
    0
    NaN
    Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
    1
    2.7%
    0
    NaN
    Inf (clin/microbio) w/Gr 3-4 neuts - Skin
    1
    2.7%
    0
    NaN
    Inf w/normal ANC or Gr 1-2 neutrophils - Blood
    0
    0%
    1
    NaN
    Leukocytes (total WBC)
    14
    37.8%
    4
    NaN
    Lymphopenia
    2
    5.4%
    0
    NaN
    Muscle weakness, not d/t neuropathy - body/general
    3
    8.1%
    0
    NaN
    Nausea
    1
    2.7%
    0
    NaN
    Neuropathy: motor
    1
    2.7%
    0
    NaN
    Neutrophils/granulocytes (ANC/AGC)
    16
    43.2%
    5
    NaN
    Platelets
    21
    56.8%
    3
    NaN
    Pneumonitis/pulmonary infiltrates
    4
    10.8%
    0
    NaN
    Potassium, serum-low (hypokalemia)
    3
    8.1%
    0
    NaN
    Pulmonary/Upper Respiratory-Other (Specify)
    2
    5.4%
    0
    NaN
    Rash/desquamation
    2
    5.4%
    0
    NaN
    Renal failure
    1
    2.7%
    0
    NaN
    Sodium, serum-high (hypernatremia)
    1
    2.7%
    0
    NaN
    Sodium, serum-low (hyponatremia)
    1
    2.7%
    1
    NaN
    Vomiting
    1
    2.7%
    0
    NaN
    2. Secondary Outcome
    Title Cytogenetic Abnormalities
    Description Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.
    Time Frame Up to 5 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Responders Nonresponders
    Arm/Group Description Eligible and evaluable patients who achieved CR/CRi/PR Eligible and evaluable patients who did not achieve CR/CRi/PR
    Measure Participants 5 32
    Median (Full Range) [Number of abnormalities]
    8
    8
    3. Secondary Outcome
    Title Total Response
    Description Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.
    Time Frame Up to 5 years

    Outcome Measure Data

    Analysis Population Description
    Eligible patients who began protocol therapy
    Arm/Group Title Induction Therapy
    Arm/Group Description Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
    Measure Participants 37
    Number (95% Confidence Interval) [percentage of participants]
    14
    37.8%
    4. Primary Outcome
    Title Complete Response
    Description Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl.
    Time Frame Up to 5 years

    Outcome Measure Data

    Analysis Population Description
    Eligible patients who began protocol therapy
    Arm/Group Title Induction Therapy
    Arm/Group Description Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
    Measure Participants 37
    Number (95% Confidence Interval) [percentage of participants]
    11
    29.7%

    Adverse Events

    Time Frame Up to 5 years
    Adverse Event Reporting Description
    Arm/Group Title Induction Therapy Maintenance Therapy
    Arm/Group Description Oral lenalidomide once daily on days 1-14, 1-21, or 1-28 Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
    All Cause Mortality
    Induction Therapy Maintenance Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Induction Therapy Maintenance Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 24/37 (64.9%) 4/8 (50%)
    Blood and lymphatic system disorders
    Blood/Bone Marrow-Other (Specify) 1/37 (2.7%) 0/8 (0%)
    Febrile neutropenia 5/37 (13.5%) 2/8 (25%)
    Hemoglobin 2/37 (5.4%) 0/8 (0%)
    Cardiac disorders
    Cardiac-ischemia/infarction 2/37 (5.4%) 0/8 (0%)
    Gastrointestinal disorders
    Diarrhea 1/37 (2.7%) 0/8 (0%)
    Hemorrhage, GI - Colon 0/37 (0%) 1/8 (12.5%)
    General disorders
    Death not associated with CTCAE term - Death NOS 1/37 (2.7%) 0/8 (0%)
    Fatigue (asthenia, lethargy, malaise) 3/37 (8.1%) 0/8 (0%)
    Infections and infestations
    Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus 1/37 (2.7%) 0/8 (0%)
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung 3/37 (8.1%) 0/8 (0%)
    Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums 1/37 (2.7%) 0/8 (0%)
    Inf w/normal ANC or Gr 1-2 neutrophils - Blood 1/37 (2.7%) 1/8 (12.5%)
    Inf w/normal ANC or Gr 1-2 neutrophils - Lung 1/37 (2.7%) 0/8 (0%)
    Infection with unknown ANC - Blood 1/37 (2.7%) 0/8 (0%)
    Investigations
    ALT, SGPT (serum glutamic pyruvic transaminase) 1/37 (2.7%) 0/8 (0%)
    AST, SGOT 1/37 (2.7%) 0/8 (0%)
    Leukocytes (total WBC) 0/37 (0%) 1/8 (12.5%)
    Lymphopenia 1/37 (2.7%) 0/8 (0%)
    Platelets 3/37 (8.1%) 1/8 (12.5%)
    Metabolism and nutrition disorders
    Calcium, serum-low (hypocalcemia) 1/37 (2.7%) 0/8 (0%)
    Dehydration 1/37 (2.7%) 0/8 (0%)
    Potassium, serum-low (hypokalemia) 1/37 (2.7%) 0/8 (0%)
    Musculoskeletal and connective tissue disorders
    Muscle weakness, not d/t neuropathy - body/general 1/37 (2.7%) 0/8 (0%)
    Pain - Back 0/37 (0%) 1/8 (12.5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Death - Disease progression NOS 8/37 (21.6%) 1/8 (12.5%)
    Nervous system disorders
    Pain - Head/headache 1/37 (2.7%) 0/8 (0%)
    Syncope (fainting) 1/37 (2.7%) 0/8 (0%)
    Renal and urinary disorders
    Renal failure 1/37 (2.7%) 0/8 (0%)
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome (ARDS) 1/37 (2.7%) 0/8 (0%)
    Aspiration 1/37 (2.7%) 0/8 (0%)
    Dyspnea (shortness of breath) 3/37 (8.1%) 1/8 (12.5%)
    Pneumonitis/pulmonary infiltrates 3/37 (8.1%) 0/8 (0%)
    Skin and subcutaneous tissue disorders
    Induration/fibrosis (skin and subcutaneous tissue) 0/37 (0%) 1/8 (12.5%)
    Rash/desquamation 1/37 (2.7%) 0/8 (0%)
    Other (Not Including Serious) Adverse Events
    Induction Therapy Maintenance Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 34/37 (91.9%) 8/8 (100%)
    Blood and lymphatic system disorders
    Febrile neutropenia 11/37 (29.7%) 0/8 (0%)
    Hemoglobin 23/37 (62.2%) 5/8 (62.5%)
    Gastrointestinal disorders
    Constipation 3/37 (8.1%) 1/8 (12.5%)
    Diarrhea 8/37 (21.6%) 2/8 (25%)
    Distention/bloating, abdominal 0/37 (0%) 1/8 (12.5%)
    Dry mouth/salivary gland (xerostomia) 2/37 (5.4%) 0/8 (0%)
    Nausea 7/37 (18.9%) 1/8 (12.5%)
    Obstruction, GI - Small bowel NOS 0/37 (0%) 1/8 (12.5%)
    Pain - Abdomen NOS 0/37 (0%) 1/8 (12.5%)
    Vomiting 3/37 (8.1%) 2/8 (25%)
    General disorders
    Edema: limb 9/37 (24.3%) 2/8 (25%)
    Fatigue (asthenia, lethargy, malaise) 18/37 (48.6%) 5/8 (62.5%)
    Fever in absence of neutropenia, ANC lt1.0x10e9/L 3/37 (8.1%) 1/8 (12.5%)
    Pain - Pain NOS 2/37 (5.4%) 0/8 (0%)
    Rigors/chills 4/37 (10.8%) 0/8 (0%)
    Infections and infestations
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung 5/37 (13.5%) 0/8 (0%)
    Investigations
    ALT, SGPT (serum glutamic pyruvic transaminase) 4/37 (10.8%) 0/8 (0%)
    AST, SGOT 6/37 (16.2%) 1/8 (12.5%)
    Alkaline phosphatase 2/37 (5.4%) 1/8 (12.5%)
    Bilirubin (hyperbilirubinemia) 9/37 (24.3%) 1/8 (12.5%)
    Creatinine 8/37 (21.6%) 1/8 (12.5%)
    Leukocytes (total WBC) 20/37 (54.1%) 5/8 (62.5%)
    Lymphopenia 2/37 (5.4%) 0/8 (0%)
    Neutrophils/granulocytes (ANC/AGC) 20/37 (54.1%) 5/8 (62.5%)
    Platelets 24/37 (64.9%) 5/8 (62.5%)
    Metabolism and nutrition disorders
    Albumin, serum-low (hypoalbuminemia) 8/37 (21.6%) 2/8 (25%)
    Anorexia 6/37 (16.2%) 2/8 (25%)
    Calcium, serum-low (hypocalcemia) 11/37 (29.7%) 2/8 (25%)
    Dehydration 2/37 (5.4%) 1/8 (12.5%)
    Glucose, serum-high (hyperglycemia) 15/37 (40.5%) 2/8 (25%)
    Magnesium, serum-low (hypomagnesemia) 4/37 (10.8%) 1/8 (12.5%)
    Phosphate, serum-low (hypophosphatemia) 0/37 (0%) 1/8 (12.5%)
    Potassium, serum-high (hyperkalemia) 0/37 (0%) 1/8 (12.5%)
    Potassium, serum-low (hypokalemia) 4/37 (10.8%) 1/8 (12.5%)
    Sodium, serum-low (hyponatremia) 7/37 (18.9%) 1/8 (12.5%)
    Musculoskeletal and connective tissue disorders
    Muscle weakness, not d/t neuropathy - Extrem-lower 0/37 (0%) 1/8 (12.5%)
    Muscle weakness, not d/t neuropathy - body/general 4/37 (10.8%) 1/8 (12.5%)
    Pain - Bone 0/37 (0%) 1/8 (12.5%)
    Pain - Extremity-limb 0/37 (0%) 1/8 (12.5%)
    Nervous system disorders
    Dizziness 2/37 (5.4%) 0/8 (0%)
    Neuropathy: motor 2/37 (5.4%) 0/8 (0%)
    Neuropathy: sensory 4/37 (10.8%) 0/8 (0%)
    Pain - Head/headache 3/37 (8.1%) 1/8 (12.5%)
    Taste alteration (dysgeusia) 2/37 (5.4%) 1/8 (12.5%)
    Psychiatric disorders
    Mood alteration - anxiety 4/37 (10.8%) 0/8 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 6/37 (16.2%) 0/8 (0%)
    Dyspnea (shortness of breath) 6/37 (16.2%) 0/8 (0%)
    Hemorrhage, pulmonary/upper respiratory - Nose 3/37 (8.1%) 1/8 (12.5%)
    Pleural effusion (non-malignant) 2/37 (5.4%) 0/8 (0%)
    Pneumonitis/pulmonary infiltrates 2/37 (5.4%) 0/8 (0%)
    Pulmonary/Upper Respiratory-Other (Specify) 2/37 (5.4%) 0/8 (0%)
    Skin and subcutaneous tissue disorders
    Dry skin 2/37 (5.4%) 1/8 (12.5%)
    Induration/fibrosis (skin and subcutaneous tissue) 0/37 (0%) 1/8 (12.5%)
    Petechiae/purpura (hemorrhage into skin or mucosa) 4/37 (10.8%) 1/8 (12.5%)
    Pruritus/itching 7/37 (18.9%) 1/8 (12.5%)
    Rash/desquamation 9/37 (24.3%) 2/8 (25%)
    Vascular disorders
    Hematoma 0/37 (0%) 1/8 (12.5%)
    Hot flashes/flushes 0/37 (0%) 1/8 (12.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Study Statistician
    Organization SWOG
    Phone 206-667-4623
    Email
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00352365
    Other Study ID Numbers:
    • NCI-2009-00785
    • NCI-2009-00785
    • SWOG-S0605
    • CDR0000484449
    • S0605
    • S0605
    • U10CA032102
    First Posted:
    Jul 14, 2006
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Jan 1, 2022