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S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer

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ClinicalTrials.gov Identifier: NCT00107276
Recruitment Status : Completed
First Posted : April 6, 2005
Results First Posted : June 27, 2013
Last Update Posted : July 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: capecitabine
Drug: cyclophosphamide
Enrollment 112
Recruitment Details Between 8/15/2005 and 9/1/2007, 112 patients were registered from 26 SWOG institutions who obtained Institutional Review Board (IRB) approval for the study.
Pre-assignment Details  
Arm/Group Title Cyclophosphamide and Capecitabine
Hide Arm/Group Description cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Period Title: Overall Study
Started 112
Eligible 96
Completed 40
Not Completed 72
Reason Not Completed
Progression             46
Adverse Event             6
M.D. decision             2
Patient refusal             1
Death             1
Ineligible             16
Arm/Group Title Cyclophosphamide and Capecitabine
Hide Arm/Group Description cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Overall Number of Baseline Participants 96
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 96 participants
59.7
(34.3 to 88.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants
Female
96
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Hide Description Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time Frame Patients assessed at least every six weeks while on protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with RECIST measurable disease
Arm/Group Title Cyclophosphamide and Capecitabine
Hide Arm/Group Description:
cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: participants
29
2.Secondary Outcome
Title Progression-free Survival and Overall Survival
Hide Description

Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.

Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact.

Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Time Frame two years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients
Arm/Group Title Cyclophosphamide and Capecitabine
Hide Arm/Group Description:
cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Overall Number of Participants Analyzed 96
Median (95% Confidence Interval)
Unit of Measure: months
PFS
5.9
(3.7 to 8.0)
OS
18.8
(13.1 to 22.0)
3.Secondary Outcome
Title Toxicity
Hide Description Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Arm/Group Title Cyclophosphamide and Capecitabine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 1
Alkaline phosphatase 1
Dehydration 2
Diarrhea 2
Dyspnea (shortness of breath) 1
Fatigue (asthenia, lethargy, malaise) 2
Febrile neutropenia 1
Hemoglobin 1
Leukocytes (total WBC) 15
Lymphopenia 13
Mood alteration - depression 1
Nausea 1
Neuroendocrine: ADH secretion abnormality 1
Neutrophils/granulocytes (ANC/AGC) 7
Platelets 1
Potassium, serum-low (hypokalemia) 1
Pruritus/itching 1
Rash/desquamation 1
Rash: hand-foot skin reaction 7
Sodium, serum-low (hyponatremia) 1
Thrombosis/thrombus/embolism 2
Weight loss 1
Time Frame Every 3 weeks for up to 2 years.
Adverse Event Reporting Description Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
 
Arm/Group Title Cyclophosphamide and Capecitabine
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Cyclophosphamide and Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cyclophosphamide and Capecitabine
Affected / at Risk (%)
Total   4/95 (4.21%) 
General disorders   
Death not associated with CTCAE term - Death NOS  1  1/95 (1.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS  1  2/95 (2.11%) 
Nervous system disorders   
CNS cerebrovascular ischemia  1  1/95 (1.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cyclophosphamide and Capecitabine
Affected / at Risk (%)
Total   92/95 (96.84%) 
Blood and lymphatic system disorders   
Hemoglobin  1  40/95 (42.11%) 
Gastrointestinal disorders   
Constipation  1  16/95 (16.84%) 
Diarrhea  1  32/95 (33.68%) 
Heartburn/dyspepsia  1  10/95 (10.53%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  8/95 (8.42%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  5/95 (5.26%) 
Nausea  1  53/95 (55.79%) 
Pain - Abdomen NOS  1  6/95 (6.32%) 
Vomiting  1  28/95 (29.47%) 
General disorders   
Edema: limb  1  11/95 (11.58%) 
Fatigue (asthenia, lethargy, malaise)  1  61/95 (64.21%) 
Pain-Other (Specify)  1  10/95 (10.53%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  12/95 (12.63%) 
AST, SGOT  1  18/95 (18.95%) 
Alkaline phosphatase  1  19/95 (20.00%) 
Bilirubin (hyperbilirubinemia)  1  11/95 (11.58%) 
Leukocytes (total WBC)  1  43/95 (45.26%) 
Lymphopenia  1  21/95 (22.11%) 
Neutrophils/granulocytes (ANC/AGC)  1  29/95 (30.53%) 
Platelets  1  13/95 (13.68%) 
Weight loss  1  8/95 (8.42%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  5/95 (5.26%) 
Anorexia  1  23/95 (24.21%) 
Calcium, serum-low (hypocalcemia)  1  7/95 (7.37%) 
Glucose, serum-high (hyperglycemia)  1  29/95 (30.53%) 
Potassium, serum-low (hypokalemia)  1  8/95 (8.42%) 
Sodium, serum-low (hyponatremia)  1  12/95 (12.63%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, not d/t neuropathy - body/general  1  5/95 (5.26%) 
Pain - Back  1  10/95 (10.53%) 
Pain - Bone  1  13/95 (13.68%) 
Pain - Extremity-limb  1  8/95 (8.42%) 
Pain - Joint  1  7/95 (7.37%) 
Nervous system disorders   
Dizziness  1  12/95 (12.63%) 
Neuropathy: sensory  1  14/95 (14.74%) 
Pain - Head/headache  1  8/95 (8.42%) 
Taste alteration (dysgeusia)  1  9/95 (9.47%) 
Psychiatric disorders   
Insomnia  1  6/95 (6.32%) 
Mood alteration - anxiety  1  11/95 (11.58%) 
Mood alteration - depression  1  15/95 (15.79%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  8/95 (8.42%) 
Cough  1  10/95 (10.53%) 
Dyspnea (shortness of breath)  1  20/95 (21.05%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  7/95 (7.37%) 
Hair loss/Alopecia (scalp or body)  1  5/95 (5.26%) 
Nail changes  1  7/95 (7.37%) 
Rash/desquamation  1  5/95 (5.26%) 
Rash: hand-foot skin reaction  1  37/95 (38.95%) 
Vascular disorders   
Hot flashes/flushes  1  7/95 (7.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study statistician
Organization: SWOG
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00107276     History of Changes
Other Study ID Numbers: CDR0000423180
S0430 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: April 5, 2005
First Posted: April 6, 2005
Results First Submitted: November 15, 2012
Results First Posted: June 27, 2013
Last Update Posted: July 18, 2013