Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
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:
-
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.
-
Estimate the frequency and severity of toxicities of this drug in these patients.
-
Correlate, in a preliminary manner, additional cytogenetic abnormalities with response to lenalidomide.
-
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
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- Cytogenetic Abnormalities [Up to 5 years]
Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.
- 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
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.- NCI-2009-00785
- NCI-2009-00785
- SWOG-S0605
- CDR0000484449
- S0605
- S0605
- U10CA032102
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
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
|
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
|
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%
|
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
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 |
- NCI-2009-00785
- NCI-2009-00785
- SWOG-S0605
- CDR0000484449
- S0605
- S0605
- U10CA032102