Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00005908
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 91
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study will assess the usefulness of a technique called complementary deoxyribonucleic acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study will look for "markers" that can help select the most effective type of chemotherapy. It will also evaluate the safety and effectiveness of a new drug combination of capecitabine and docetaxel.

Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study. Those enrolled will be treated with surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), and the capecitabine and docetaxel combination.

Patients will have a physical examination, mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment. They will then have four 21-day treatment cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be given from days 16 through 21. This regimen will be repeated four times, after which the tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance imaging.

Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four 21-day cycles.

Some patients who had a mastectomy (depending on their tumor characteristics and whether tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also have radiation therapy. Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years.

In addition to the above procedures, all patients will have tumor biopsies (removal of a small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2, and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood tests at various times during the study. Patients will be followed at National Institutes of Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and computed tomography (CT) scans.

Although it is not known whether this treatment will help an individual patient's cancer, possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition, the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Breast Neoplasm	Drug: Docetaxel - Dose A; Drug: Anastrozole; Drug: cyclophosphamide; Drug: Docetaxel - Dose B; Drug: Doxorubicin hydrochloride; Drug: Tamoxifen Citrate; Drug: Capecitabine - Dose B; Drug: Capecitabine - Dose A	Phase 2

Detailed Description

This phase II trial in patients with stage II and stage III breast cancer will test the feasibility of using cDNA microarray as a measure of a tumor's biological response to chemotherapeutic agents by characterizing the cDNA expression patterns in breast cancer before and after primary chemotherapy. Thirty-six patients receive docetaxel/capecitabine induction chemotherapy followed by surgery and doxorubicin/cyclophosphamide adjuvant therapy (TX/AC). We will determine the response rate of TX induction therapy and the toxicities of the sequential combinations (TX/AC). We will also obtain tumor tissue for correlative biological determinations.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Trial of Sequential Primary (Neoadjuvant) Combination Chemotherapy With Docetaxel/Capecitabine (TX) and Doxorubicin/Cyclophosphamide (AC) in Primary Breast Cancer With Evaluation of Chemotherapy Effects on Gene Expression
• Study Start Date: Jun 1, 2000
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles	Drug: Docetaxel - Dose A; Dose A-Cohort 1 Docetaxel 75 mg/m^2 intravenous day 1; Other Names: Taxotere/Xeloda ; Drug: Anastrozole; 1 mg orally daily for five years; Other Names: Arimidex ; Drug: cyclophosphamide; 600 mg/m^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1; Other Names: Cytoxan ; Drug: Doxorubicin hydrochloride; 60 mg/m^2 will be administered as a slow intravenous push on day 1; Other Names: Adriamycin ; Drug: Tamoxifen Citrate; 20 mg/day orally for five years; Other Names: Nolvadex ; Drug: Capecitabine - Dose A; capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
Experimental: Dose B-Cohort 2-Arm 2 Reduced dose-Docetaxel & Capecitabine Docetaxel 60 mg/m^2 intravenous day 1, capecitabine 937.5 mg/m^2 orally twice daily day 2-15 for 4 cycles	Drug: Anastrozole; 1 mg orally daily for five years; Other Names: Arimidex ; Drug: cyclophosphamide; 600 mg/m^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1; Other Names: Cytoxan ; Drug: Docetaxel - Dose B; Dose B - Cohort 2 Docetaxel 60 mg/m^2 intravenous day 1; Other Names: Taxotere ; Drug: Doxorubicin hydrochloride; 60 mg/m^2 will be administered as a slow intravenous push on day 1; Other Names: Adriamycin ; Drug: Tamoxifen Citrate; 20 mg/day orally for five years; Other Names: Nolvadex ; Drug: Capecitabine - Dose B; Dose B - Cohort 2 capecitabine 937.5 mg/m^2 orally twice daily day 2-15

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [6 years]

   Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

2. Overall Clinical Response Rate [6 years]

   Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module.

3. Complementary Deoxyribonucleic Acid (cDNA) Expression [6 years]

   Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.

4. Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models [6 years]

   Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• INCLUSION CRITERIA:

Stage II or III breast cancer with a tumor size of greater than 2 cm. Patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study.

At least 18 years of age.

Adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm^{3 and platelet count greater than 100,000/mm}3.

Adequate renal function as defined by creatinine less than 1.6 mg/dL.

Adequate hepatic function as defined by total (T.) bilirubin less than 1.4 mg/dL and serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal

Zubrod Performance status 0-2.

EXCLUSION CRITERIA:

Medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude chemotherapy administration. Patients may be evaluated by psychiatry or medical subspecialties as appropriate.

Pregnant or lactating women

Known bleeding disorders

Hypersensitivity to Tween 80 (Polysorbate)

Cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention.

Prior chemotherapy or hormonal therapy for breast cancer. Patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible.

Active malignancy diagnosed within the last 5 years. (Cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Naval Medical Center	Bethesda	Maryland	United States	20889

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: JoAnne Zujewski, M.D., National Cancer Institute (NCI), National Institutes of Health (NIH)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• RECIST

Publications

• Elledge RM, Gray R, Mansour E, Yu Y, Clark GM, Ravdin P, Osborne CK, Gilchrist K, Davidson NE, Robert N, et al. Accumulation of p53 protein as a possible predictor of response to adjuvant combination chemotherapy with cyclophosphamide, methotrexate, fluorouracil, and prednisone for breast cancer. J Natl Cancer Inst. 1995 Aug 16;87(16):1254-6.
• Harvey JM, Clark GM, Osborne CK, Allred DC. Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. J Clin Oncol. 1999 May;17(5):1474-81.
• MacGrogan G, Mauriac L, Durand M, Bonichon F, Trojani M, de Mascarel I, Coindre JM. Primary chemotherapy in breast invasive carcinoma: predictive value of the immunohistochemical detection of hormonal receptors, p53, c-erbB-2, MiB1, pS2 and GST pi. Br J Cancer. 1996 Nov;74(9):1458-65.

• Responsible Party: Jo Anne Zujewski, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
• ClinicalTrials.gov Identifier: NCT00005908
• Other Study ID Numbers: 000149; 00-C-0149; NCT00020241
• First Posted: Jun 14, 2000
• Last Update Posted: Mar 19, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Jo Anne Zujewski, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC): cDNA Microarray; Stage II and Stage III Breast Cancer; Biological Response; Molecular Profiling; Fine Needle Aspirate; Breast Cancer
• Additional relevant MeSH terms: Breast Neoplasms; Tamoxifen; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Capecitabine; Anastrozole

Study Results

Participant Flow

Arm/Group Title	Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine	Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
Arm/Group Description	Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.	Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
Period Title: Overall Study
STARTED	10	20
COMPLETED	9	20
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Docetaxel/Capecitabine - A & B
Arm/Group Description	Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	29 96.7%
>=65 years	1 3.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (9.80)
Sex: Female, Male (Count of Participants)
Female	30 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 10%
Not Hispanic or Latino	27 90%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Number) [Number]
White	15 50%
African American	6 20%
Asian	6 20%
Hispanic	3 10%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame	6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine	Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
Arm/Group Description	Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.	Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
Measure Participants	9	20
Number [Participants]	9 30%	20 NaN

2. Primary Outcome

Title	Overall Clinical Response Rate
Description	Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module.
Time Frame	6 years

Outcome Measure Data

Analysis Population Description

Combined data from 2 dose levels in 29 evaluable patients.

Arm/Group Title	Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine
Arm/Group Description	Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
Measure Participants	29
Complete Response	31 103.3%
Partial Response	59 196.7%
Complete pathologic response	10 33.3%

3. Primary Outcome

Title	Complementary Deoxyribonucleic Acid (cDNA) Expression
Description	Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.
Time Frame	6 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine	Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine
Arm/Group Description	Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles	Docetaxel 60 mg/m^2 intravenous day 1, capecitabine 937.5 mg/m^2 orally twice daily day 2-15
Measure Participants	10	20
Responders	8 26.7%	7 NaN
Non-responders	2 6.7%	13 NaN

4. Primary Outcome

Title	Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models
Description	Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.
Time Frame	6 years

Outcome Measure Data

Analysis Population Description

Specimens from 21 patients. Analysis was "per protocol" and included only those patients with adequate RNA (ribonucleic acid) for analysis. Since both had the same intervention, the sample size was small, and a dose response was not expected, all patients were analyzed together.

Arm/Group Title	Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine
Arm/Group Description	Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
Measure Participants	21
Responders	8 26.7%
Non-responders	13 43.3%

Adverse Events

Time Frame	6 years
Adverse Event Reporting Description	CTC version 2.0 criteria for adverse event report. If a specific description was not available in the standard 'CTC" criteria the event was categorized by the major class and "other".
Arm/Group Title	Docetaxel/Capecitabine - A & B
Arm/Group Description	Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15
All Cause Mortality
	Docetaxel/Capecitabine - A & B
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Docetaxel/Capecitabine - A & B
	Affected / at Risk (%)	# Events
Total	29/30 (96.7%)
Blood and lymphatic system disorders
Febrile neutropenia	3/30 (10%)	4
Lymphatics	1/30 (3.3%)	1
Gastrointestinal disorders
Diarrhea (without colostomy)	5/30 (16.7%)	5
Abdominal pain or cramping	2/30 (6.7%)	2
Colitis	1/30 (3.3%)	1
Dehydration	1/30 (3.3%)	2
Nausea	1/30 (3.3%)	1
Stomatitis/pharyngitis (oral/pharyngeal/mucositis)	1/30 (3.3%)	1
Vomiting	1/30 (3.3%)	1
General disorders
Fatigue (lethargy, malaise, asthenia)	3/30 (10%)	3
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)	2/30 (6.7%)	2
Infections and infestations
Infection, Other	5/30 (16.7%)	5
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia	4/30 (13.3%)	4
Infection without neutropenia	2/30 (6.7%)	3
Injury, poisoning and procedural complications
Injection site reaction	1/30 (3.3%)	1
Wound-infectious	1/30 (3.3%)	1
Wound-non-infectious	1/30 (3.3%)	1
Investigations
Leukocytes (total WBC)	12/30 (40%)	44
Neutrophils/granulocytes (ANC/AGC)	26/30 (86.7%)	135
SGOT (AST)	1/30 (3.3%)	1
SGPT (ALT)	1/30 (3.3%)	1
Metabolism and nutrition disorders
Hyperglycemia	5/30 (16.7%)	13
Hypokalemia	1/30 (3.3%)	1
Hyponatremia	1/30 (3.3%)	1
Hypophosphatemia	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
Myalgia (muscle ache)	2/30 (6.7%)	2
Arthralgia (joint pain)	1/30 (3.3%)	1
Bone pain	1/30 (3.3%)	1
Nervous system disorders
Neuropathy-sensory	1/30 (3.3%)	1
Headache	1/30 (3.3%)	1
Syncope	1/30 (3.3%)	1
Psychiatric disorders
Mood alteration-depression	1/30 (3.3%)	1
Renal and urinary disorders
Urinary frequency/urgency	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)	1/30 (3.3%)	1
Skin and subcutaneous tissue disorders
Hand/foot skin reaction	13/30 (43.3%)	16
Urticaria (hives, welts, wheals)	1/30 (3.3%)	1
Anorexia	1/30 (3.3%)	1
Vascular disorders
Thrombosis/embolism	2/30 (6.7%)	2
Other (Not Including Serious) Adverse Events
	Docetaxel/Capecitabine - A & B
	Affected / at Risk (%)	# Events
Total	29/30 (96.7%)
Blood and lymphatic system disorders
Hematologic-Other	2/30 (6.7%)	2
Lymphatics	4/30 (13.3%)	4
Lymphatics-Other	1/30 (3.3%)	1
Vaginal bleeding	1/30 (3.3%)	3
Cardiac disorders
Palpitation	2/30 (6.7%)	3
Ear and labyrinth disorders
Hearing-Other	1/30 (3.3%)	1
Eye disorders
Dry eye	2/30 (6.7%)	2
Ocular-Other	1/30 (3.3%)	1
Tearing (watery eyes)	9/30 (30%)	12
Vision-blurred vision	3/30 (10%)	4
Gastrointestinal disorders
Diarrhea (without colostomy)	10/30 (33.3%)	24
Abdominal pain or cramping	4/30 (13.3%)	6
Constipation	7/30 (23.3%)	15
Dehydration	2/30 (6.7%)	2
Dyspepsia/heartburn	2/30 (6.7%)	2
Dysphagia, esophagitis, odynophagia (painful swallowing)	1/30 (3.3%)	1
Flatulence	2/30 (6.7%)	3
GI-Other	2/30 (6.7%)	2
Mouth dryness	2/30 (6.7%)	2
Nausea	12/30 (40%)	34
Stomatitis/pharyngitis (oral/pharyngeal mucositis)	13/30 (43.3%)	22
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT	1/30 (3.3%)	1
Taste disturbance (dysgeusia)	10/30 (33.3%)	21
Vomiting	8/30 (26.7%)	21
Anorexia	8/30 (26.7%)	15
General disorders
Chest pain (non-cardiac and non-pleuritic)	3/30 (10%)	4
Edema	2/30 (6.7%)	2
Fatigue (lathargy, malaise, asthenia)	18/30 (60%)	53
Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L)	2/30 (6.7%)	4
Pain-Other	9/30 (30%)	13
Syndromes-Other	1/30 (3.3%)	1
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)	2/30 (6.7%)	2
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	4/30 (13.3%)	5
Allergy-Other	1/30 (3.3%)	1
Infections and infestations
Infection without neutropenia	11/30 (36.7%)	18
Infection, Other	3/30 (10%)	3
Injury, poisoning and procedural complications
Injection site reaction	1/30 (3.3%)	1
Investigations
Bilirubin	5/30 (16.7%)	5
Creatinine	1/30 (3.3%)	1
Hemoglobin (hgb)	9/30 (30%)	39
Leukocytes (total WBC)	21/30 (70%)	103
Neutrophils/granulocytes (ANC/AGC)	25/30 (83.3%)	71
Platelets	3/30 (10%)	5
Weight loss	1/30 (3.3%)	1
Metabolism and nutrition disorders
Alkaline phosphatase	1/30 (3.3%)	1
Hyperglycemia	14/30 (46.7%)	36
Hyperuricemia	1/30 (3.3%)	2
Hypoalbuminemia	7/30 (23.3%)	13
Hypokalemia	1/30 (3.3%)	2
Hypomagnesemia	3/30 (10%)	5
Hyponatremia	2/30 (6.7%)	2
Hypophosphatemia	1/30 (3.3%)	1
Metabolic-Other	1/30 (3.3%)	1
SGOT (AST)	5/30 (16.7%)	9
SGPT (ALT)	6/30 (20%)	12
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)	7/30 (23.3%)	11
Bone pain	4/30 (13.3%)	9
Muscle weakness (not due to neuropathy)	4/30 (13.3%)	5
Myalgia (muscle ache)	9/30 (30%)	17
Nervous system disorders
Memory loss	3/30 (10%)	3
Depressed level of consciousness	1/30 (3.3%)	1
Dizziness/lightheadedness	1/30 (3.3%)	1
Neuropathy motor	1/30 (3.3%)	1
Neuro-sensory	10/30 (33.3%)	17
Psychiatric disorders
Headache	8/30 (26.7%)	9
Insomnia	4/30 (13.3%)	4
Mood alteration-anxiety/agitation	7/30 (23.3%)	9
Mood alteration-depression	8/30 (26.7%)	12
Renal and urinary disorders
Hematuria (in absence of vaginal bleeding)	1/30 (3.3%)	2
Renal/GU-Other	1/30 (3.3%)	2
Reproductive system and breast disorders
Dysmenorrhea	2/30 (6.7%)	2
Irregular menses (change from baseline)	3/30 (10%)	3
Libido	4/30 (13.3%)	4
Sexual/reproductive function-Other	5/30 (16.7%)	5
Respiratory, thoracic and mediastinal disorders
Cough	2/30 (6.7%)	3
Dyspnea (shortness of breath)	2/30 (6.7%)	2
Hypoxia	1/30 (3.3%)	1
Pulmonary-Other	1/30 (3.3%)	1
Skin and subcutaneous tissue disorders
Alopecia	22/30 (73.3%)	26
Dermatitis, focal (associated with high-dose chemotherapy and bone marrow transplant)	1/30 (3.3%)	1
Dry skin	1/30 (3.3%)	1
Hand-foot skin reaction	11/30 (36.7%)	26
Nail changes	10/30 (33.3%)	11
Pigmentation changes (e.g., vitiligo)	3/30 (10%)	3
Pruritis	2/30 (6.7%)	2
Radiation dermatitis	2/30 (6.7%)	2
Rash/desquamation	3/30 (10%)	3
Skin-Other	3/30 (10%)	3
Sweating (diaphoresis)	1/30 (3.3%)	1
Vascular disorders
Hot flashes/flashes	16/30 (53.3%)	22
Hypotension	2/30 (6.7%)	2
Phlebitis (superficial)	2/30 (6.7%)	2

Limitations/Caveats

[Not Specified]

More Information

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.