A Study of Xeloda (Capecitabine) in Women With HER2-Negat... | NCT00121836

Status Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: Capecitabine Drug: Bevacizumab

Name	Type	Description	Arm Group Labels	Other Names
Capecitabine	Drug	1000 mg/m² PO BID on Days 1-15 of each 3-week cycle	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death	approximately 505 days (Median Time to Death)

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Adverse Events	The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution.

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35022	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev	First Study Treatment Phase: Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle. Second Study Treatment Phase: Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed. Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle. Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev	First Study Treatment Phase: Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle. Second Study Treatment Phase: Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed. Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle. Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival

Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death

109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.

Posted

Median

95% Confidence Interval

Days

approximately 505 days (Median Time to Death)

ID	Title	Description
OG000	Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev	First Study Treatment Phase: Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle. Second Study Treatment Phase: Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed. Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle. Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.

Units	Counts
Participants	OG000109

Title

Denominators

Categories

Title	Measurements
	OG000505(420 to 672)

Secondary

Number of Subjects With Adverse Events

The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.

Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution.

Posted

Number

Participants

Throughout study

ID	Title	Description
OG000	Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev	First Study Treatment Phase: Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle. Second Study Treatment Phase: Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed. Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle. Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.

Secondary

Premature Withdrawal From Study Due to Adverse Events

The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.

Posted

Number

Participants

Throughout study

ID	Title	Description
OG000	Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev	First Study Treatment Phase: Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle. Second Study Treatment Phase: Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed. Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle. Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.
OG001	First Study Treatment Phase Only	Capecitabine+Bevacizumab: Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.

Secondary

Number of Participants With Marked Laboratory Abnormalities

The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in >= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.

Posted

Number

Participants

until progressive disease or for up to 3 years

ID	Title	Description
OG000	Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev	First Study Treatment Phase: Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle. Second Study Treatment Phase: Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed. Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle. Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev	First Study Treatment Phase: Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle. Second Study Treatment Phase: Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed. Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle. Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle.			39	109	103	109

Serious Adverse Events

Term	Organ System	Statistical Information
Pain	General disorders	EG0006 affected109 at risk
Chest Pain	General disorders	EG0003 affected109 at risk
Mucosal Inflammation	General disorders	EG0002 affected109 at risk
Fatigue	General disorders	EG0001 affected109 at risk
Influenza Like Illness	General disorders	EG0001 affected109 at risk
Nausea	Gastrointestinal disorders	EG0003 affected109 at risk
Vomiting	Gastrointestinal disorders	EG0003 affected109 at risk
Abdominal Pain	Gastrointestinal disorders	EG0001 affected109 at risk
Caecitis	Gastrointestinal disorders	EG0001 affected109 at risk
Diarrhoea	Gastrointestinal disorders	EG0001 affected109 at risk
Enterovesical Fistula	Gastrointestinal disorders	EG0001 affected109 at risk
Gastric Ulcer	Gastrointestinal disorders	EG0001 affected109 at risk
Pancreatitis	Gastrointestinal disorders	EG0001 affected109 at risk
Bacterial Sepsis	Infections and infestations	EG0001 affected109 at risk
Cellulitis	Infections and infestations	EG0001 affected109 at risk
Infection	Infections and infestations	EG0001 affected109 at risk
Perirectal Abscess	Infections and infestations	EG0001 affected109 at risk
Pneumonia	Infections and infestations	EG0001 affected109 at risk
Sepsis	Infections and infestations	EG0001 affected109 at risk
Urinary Tract Infection	Infections and infestations	EG0001 affected109 at risk
Urosepsis	Infections and infestations	EG0001 affected109 at risk
Dehydration	Metabolism and nutrition disorders	EG0005 affected109 at risk
Decreased Appetite	Metabolism and nutrition disorders	EG0001 affected109 at risk
Hypocalcaemia	Metabolism and nutrition disorders	EG0001 affected109 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0003 affected109 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0001 affected109 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0001 affected109 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0001 affected109 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG0002 affected109 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	EG0001 affected109 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	EG0001 affected109 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	EG0001 affected109 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	EG0001 affected109 at risk
Fall	Injury, poisoning and procedural complications	EG0001 affected109 at risk
Hip Fracture	Injury, poisoning and procedural complications	EG0001 affected109 at risk
Scapula Fracture	Injury, poisoning and procedural complications	EG0001 affected109 at risk
Cerebral Haemorrhage	Nervous system disorders	EG0001 affected109 at risk
Headache	Nervous system disorders	EG0001 affected109 at risk
Lethargy	Nervous system disorders	EG0001 affected109 at risk
Blood Sodium Decreased	Investigations	EG0001 affected109 at risk
Haemoglobin Decreased	Investigations	EG0001 affected109 at risk
Urine Output Decreased	Investigations	EG0001 affected109 at risk
Haemorrhage	Vascular disorders	EG0001 affected109 at risk
Phlebitis	Vascular disorders	EG0001 affected109 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG0001 affected109 at risk
Left Ventricular Failure	Cardiac disorders	EG0001 affected109 at risk
Metastases to Meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected109 at risk
Renal Failure	Renal and urinary disorders	EG0001 affected109 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Diarrhoea	Gastrointestinal disorders	EG00066 affected109 at risk
Nausea	Gastrointestinal disorders	EG00066 affected109 at risk
Constipation	Gastrointestinal disorders	EG00041 affected109 at risk
Vomiting	Gastrointestinal disorders	EG00036 affected109 at risk
Dyspepsia	Gastrointestinal disorders	EG00025 affected109 at risk
Stomatitis	Gastrointestinal disorders	EG00015 affected109 at risk
Abdominal Pain	Gastrointestinal disorders	EG00012 affected109 at risk
Abdominal Pain Upper	Gastrointestinal disorders	EG0008 affected109 at risk
Abdominal Distension	Gastrointestinal disorders	EG0007 affected109 at risk
Oral Pain	Gastrointestinal disorders	EG0006 affected109 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	EG00071 affected109 at risk
Alopecia	Skin and subcutaneous tissue disorders	EG00032 affected109 at risk
Rash	Skin and subcutaneous tissue disorders	EG00021 affected109 at risk
Nail Disorder	Skin and subcutaneous tissue disorders	EG00013 affected109 at risk
Pruritus	Skin and subcutaneous tissue disorders	EG00012 affected109 at risk
Erythema	Skin and subcutaneous tissue disorders	EG00010 affected109 at risk
Dry Skin	Skin and subcutaneous tissue disorders	EG0009 affected109 at risk
Skin Reaction	Skin and subcutaneous tissue disorders	EG0009 affected109 at risk
Fatigue	General disorders	EG00068 affected109 at risk
Mucosal Inflammation	General disorders	EG00030 affected109 at risk
Pyrexia	General disorders	EG00021 affected109 at risk
Pain	General disorders	EG00019 affected109 at risk
Asthenia	General disorders	EG00013 affected109 at risk
Oedema Peripheral	General disorders	EG00013 affected109 at risk
Chills	General disorders	EG0006 affected109 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG00029 affected109 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG00028 affected109 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG00021 affected109 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG00017 affected109 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	EG0009 affected109 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	EG0008 affected109 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	EG0006 affected109 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0006 affected109 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00032 affected109 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG00029 affected109 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG00027 affected109 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	EG00014 affected109 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	EG00010 affected109 at risk
Headache	Nervous system disorders	EG00032 affected109 at risk
Dysgeusia	Nervous system disorders	EG00027 affected109 at risk
Neuropathy Peripheral	Nervous system disorders	EG00020 affected109 at risk
Dizziness	Nervous system disorders	EG00014 affected109 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	EG0006 affected109 at risk
Anorexia	Metabolism and nutrition disorders	EG00035 affected109 at risk
Dehydration	Metabolism and nutrition disorders	EG0008 affected109 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0006 affected109 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0006 affected109 at risk
Insomnia	Psychiatric disorders	EG00022 affected109 at risk
Depression	Psychiatric disorders	EG00021 affected109 at risk
Anxiety	Psychiatric disorders	EG00012 affected109 at risk
Neutropenia	Blood and lymphatic system disorders	EG00024 affected109 at risk
Anaemia	Blood and lymphatic system disorders	EG00021 affected109 at risk
Sinusitis	Infections and infestations	EG00015 affected109 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG00013 affected109 at risk
Urinary Tract Infection	Infections and infestations	EG00012 affected109 at risk
Hypertension	Vascular disorders	EG00029 affected109 at risk
Hot Flush	Vascular disorders	EG0006 affected109 at risk
Weight Decreased	Investigations	EG00012 affected109 at risk
Aspartate Aminotransferase Increased	Investigations	EG0008 affected109 at risk
Alanine Aminotransferase Increased	Investigations	EG0007 affected109 at risk
Neutrophil Count Decreased	Investigations	EG0007 affected109 at risk
Proteinuria	Renal and urinary disorders	EG00014 affected109 at risk
Lacrimation Increased	Eye disorders	EG0007 affected109 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins