Cetuximab and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00101192
• Collaborator: National Cancer Institute (NCI) (NIH), Bristol-Myers Squibb (Industry)
• Enrollment: 76
• Locations: 18
• Patients Per Site: 4.2

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin may be a better way to block tumor growth.

PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Biological: cetuximab; Drug: cisplatin	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of cetuximab and cisplatin, in terms of objective tumor response (partial and complete), in patients with advanced, persistent, or recurrent carcinoma of the cervix.

• Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

• Determine the progression-free survival and overall survival of patients treated with this regimen.

• Correlate epidermal growth factor receptor expression with progression-free survival, overall survival, and response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and cisplatin IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Limited Access Phase II Trial of Cetuximab (C225, NSC #714692) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Jul 1, 2011

Outcome Measures

Primary Outcome Measures

1. Tumor Response [up to 6 months from study entry]

   Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

Secondary Outcome Measures

1. Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment [up to 5 years from study entry]

Eligibility Criteria

Criteria

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

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous or non-squamous cell carcinoma of the cervix

• Advanced, persistent, or recurrent disease

• Documented disease progression

• Not amenable to curative therapy

• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• At least 1 target lesion

• Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy to confirm persistence

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Platelet count ≥ 100,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No significant history of cardiac disease within the past 6 months, including the following:

• Unstable angina

• Uncontrolled hypertension

• Uncontrolled congestive heart failure

• Uncontrolled arrhythmia

Neurologic

• No uncontrolled seizure disorder

• No active neurological disease

• No neuropathy (sensory and motor) > grade 1

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection requiring antibiotics

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior anti-epidermal growth factor receptor (EGFR) antibody therapy

• No prior chimerized or murine monoclonal antibody therapy

Chemotherapy

• Not specified

Endocrine therapy

• At least 1 week since prior anticancer hormonal therapy

• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

Surgery

• More than 30 days since prior major surgery, except diagnostic biopsy

Other

• Recovered from all prior therapy

• No prior cytotoxic therapy for cervical cancer

• No prior tyrosine kinase inhibitor therapy that targets the EGFR pathway

• No prior cancer treatment that would contraindicate study therapy

• No other concurrent investigational agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Saint Joseph Medical Center - Burbank	Burbank	California	United States	91505
2	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
3	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
4	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
5	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
6	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
7	Christus Schumpert Cancer Treatment Center	Shreveport	Louisiana	United States	71101
8	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
9	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey	United States	08043
10	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
11	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
12	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
13	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
14	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma	United States	74104
15	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
16	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052
17	University of Texas Medical Branch	Galveston	Texas	United States	77555-0361
18	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)
• Bristol-Myers Squibb

Investigators

• Study Chair: John H. Farley, MD, Uniformed Services University of the Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00101192
• Other Study ID Numbers: GOG-0076DD; BMS-CA225-075; CDR0000405839
• First Posted: Jan 10, 2005
• Last Update Posted: Mar 17, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Gynecologic Oncology Group: recurrent cervical cancer; cervical adenocarcinoma; cervical adenosquamous cell carcinoma; cervical small cell carcinoma; cervical squamous cell carcinoma; stage III cervical cancer; stage IVA cervical cancer; stage IVB cervical cancer
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Cetuximab

Study Results

Participant Flow

Arm/Group Title	Cetuximab
Arm/Group Description	Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
Period Title: Overall Study
STARTED	76
COMPLETED	69
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Cetuximab
Arm/Group Description	Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
Overall Participants	69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.8 (11.2)
Age, Customized (participants) [Number]
20-29 years	1 1.4%
30-39 years	11 15.9%
40-49 years	18 26.1%
50-59 years	26 37.7%
60-69 years	9 13%
70-79 years	4 5.8%
Sex: Female, Male (Count of Participants)
Female	69 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	69 100%
Cell Type (participants) [Number]
Adenocarcinoma, Unspecified	21 30.4%
Clear Cell Carcinoma	1 1.4%
Mucinous Adenocarcinoma	1 1.4%
Adenosquamous	5 7.2%
Squamous Cell Carcinoma	41 59.4%

Outcome Measures

1. Primary Outcome

Title	Tumor Response
Description	Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Time Frame	up to 6 months from study entry

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants

Arm/Group Title	Cetuximab
Arm/Group Description	Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
Measure Participants	69
Complete Response	1 1.4%
Partial Response	7 10.1%
Increasing Disease	17 24.6%
Stable Disease	34 49.3%
Indeterminate	10 14.5%

2. Secondary Outcome

Title	Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment
Time Frame	up to 5 years from study entry

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	from study entry up to 5 years
Adverse Event Reporting Description	All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events(SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Arm/Group Title	Cetuximab
Arm/Group Description	Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
All Cause Mortality
	Cetuximab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cetuximab
	Affected / at Risk (%)	# Events
Total	33/69 (47.8%)
Gastrointestinal disorders
Fistula, Gi - Ileum	1/69 (1.4%)
Obstruction, Gi - Colon	1/69 (1.4%)
Obstruction, Gi - Small Bowel Nos	1/69 (1.4%)
Perforation, Gi - Small Bowel Nos	1/69 (1.4%)
Vomiting	1/69 (1.4%)
Nausea	2/69 (2.9%)
Diarrhea	1/69 (1.4%)
General disorders
Death No Ctcae Term - Disease Progression Nos	2/69 (2.9%)
Pain - Other	1/69 (1.4%)
Pain: Extremity-Limb	1/69 (1.4%)
Pain: Muscle	1/69 (1.4%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	2/69 (2.9%)
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia	1/69 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	1/69 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	1/69 (1.4%)
Metabolism and nutrition disorders
Creatinine	2/69 (2.9%)
Ggt	1/69 (1.4%)
Hypomagnesemia	1/69 (1.4%)
Renal and urinary disorders
Obstruction, Gu - Urethra	1/69 (1.4%)
Obstruction, Gu - Ureter	2/69 (2.9%)
Fistula, Gu - Vagina	1/69 (1.4%)
Renal Failure	3/69 (4.3%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/69 (1.4%)
Vascular disorders
Hemorrhage, Gu - Vagina	2/69 (2.9%)
Hemorrhage/Bleeding - Other	1/69 (1.4%)
Thrombosis/Thrombus/Embolism	5/69 (7.2%)
Other (Not Including Serious) Adverse Events
	Cetuximab
	Affected / at Risk (%)	# Events
Total	66/69 (95.7%)
Blood and lymphatic system disorders
Neutrophils	13/69 (18.8%)
Platelets	13/69 (18.8%)
Leukocytes	23/69 (33.3%)
Hemolysis	1/69 (1.4%)
Hemoglobin	50/69 (72.5%)
Edema: Limb	14/69 (20.3%)
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation	1/69 (1.4%)
Palpitations	4/69 (5.8%)
S/N Arrhythmia: Sinus Tachycardia	3/69 (4.3%)
S/N Arrhythmia: Atrial Tachycardia	1/69 (1.4%)
Hypertension	4/69 (5.8%)
Hypotension	4/69 (5.8%)
Cardipulmonary Arrest	1/69 (1.4%)
Ear and labyrinth disorders
Otitis Middle Ear	1/69 (1.4%)
Tinnitus	8/69 (11.6%)
Hearing (Monitoring Program)	1/69 (1.4%)
Endocrine disorders
Hot Flashes	6/69 (8.7%)
Masculinization Of Female	1/69 (1.4%)
Eye disorders
Dry Eye	1/69 (1.4%)
Flashing Lights/Floaters	1/69 (1.4%)
Blurred Vision	15/69 (21.7%)
Gastrointestinal disorders
Fistula, Gi - Rectum	1/69 (1.4%)
Gastritis	1/69 (1.4%)
Heartburn	8/69 (11.6%)
Dental: Teeth	1/69 (1.4%)
Ileus	1/69 (1.4%)
Dysphagia	8/69 (11.6%)
Distention	1/69 (1.4%)
Taste Alteration	1/69 (1.4%)
Dry Mouth	1/69 (1.4%)
Mucositis (Functional/Sympt) - Oral Cavity	12/69 (17.4%)
Stricture, Gi - Colon	1/69 (1.4%)
Obstruction, Gi - Small Bowel Nos	1/69 (1.4%)
Mucositis (Clinical Exam) - Oral Cavity	8/69 (11.6%)
Vomiting	29/69 (42%)
Anorexia	35/69 (50.7%)
Dehydration	4/69 (5.8%)
Constipation	41/69 (59.4%)
Nausea	44/69 (63.8%)
Gastrointestinal - Other	1/69 (1.4%)
Diarrhea	20/69 (29%)
General disorders
Sweating	5/69 (7.2%)
Fever	10/69 (14.5%)
Weight Loss	8/69 (11.6%)
Rigors/Chills	5/69 (7.2%)
Fatigue	53/69 (76.8%)
Insomnia	6/69 (8.7%)
Pain - Other	2/69 (2.9%)
Pain: Pelvis	6/69 (8.7%)
Pain: Breast	1/69 (1.4%)
Pain: Vagina	1/69 (1.4%)
Pain: Chest /Thorax Nos	2/69 (2.9%)
Pain: Chest Wall	1/69 (1.4%)
Pain: Throat/Pharynx/Larynx	3/69 (4.3%)
Pain: Head/Headache	15/69 (21.7%)
Pain: Neck	1/69 (1.4%)
Pain: Extremity-Limb	15/69 (21.7%)
Pain: Buttock	1/69 (1.4%)
Pain: Back	20/69 (29%)
Pain: Joint	7/69 (10.1%)
Pain: Bone	2/69 (2.9%)
Pain: Kidney	1/69 (1.4%)
Pain: Bladder	3/69 (4.3%)
Pain: Stomach	2/69 (2.9%)
Pain: Rectum	1/69 (1.4%)
Pain: Oral Cavity	1/69 (1.4%)
Pain: Esophagus	1/69 (1.4%)
Pain: Dental/Teeth/Peridontal	1/69 (1.4%)
Pain: Abdominal Pain Nos	23/69 (33.3%)
Pain: Skin	1/69 (1.4%)
Pain: Tumor	2/69 (2.9%)
Pain: Muscle	4/69 (5.8%)
Pain: Neuralgia	1/69 (1.4%)
Flu-Like Syndrome	1/69 (1.4%)
Immune system disorders
Allergic Reaction/Hypersensitivity	9/69 (13%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Uterus	1/69 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	2/69 (2.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	2/69 (2.9%)
Inf Unknown Anc: Lung (Pneumonia)	2/69 (2.9%)
Inf Unknown Anc: Nose	1/69 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	11/69 (15.9%)
Infection - Other	1/69 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus	2/69 (2.9%)
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina	1/69 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	1/69 (1.4%)
Inf Unknown Anc: Urinary Tract Nos	1/69 (1.4%)
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)	1/69 (1.4%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	8/69 (11.6%)
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos	1/69 (1.4%)
Metabolism and nutrition disorders
Ast	6/69 (8.7%)
Metabolic/Laboratory - Other	4/69 (5.8%)
Cholesterol,serum High	2/69 (2.9%)
Proteinuria	1/69 (1.4%)
Creatinine	15/69 (21.7%)
Hypoalbuminemia	22/69 (31.9%)
Ggt	1/69 (1.4%)
Alt	10/69 (14.5%)
Alkaline Phosphatase	19/69 (27.5%)
Bilirubin	1/69 (1.4%)
Hypermagnesemia	2/69 (2.9%)
Hypophosphatemia	4/69 (5.8%)
Hyponatremia	20/69 (29%)
Cpk	1/69 (1.4%)
Bicarbonate, Serum-Low	3/69 (4.3%)
Amylase	1/69 (1.4%)
Hypernatremia	2/69 (2.9%)
Hypocalcemia	24/69 (34.8%)
Hyperkalemia	6/69 (8.7%)
Hyperglycemia	24/69 (34.8%)
Hypokalemia	22/69 (31.9%)
Hypoglycemia	2/69 (2.9%)
Hypercalcemia	1/69 (1.4%)
Hypomagnesemia	27/69 (39.1%)
Musculoskeletal and connective tissue disorders
Myositis	1/69 (1.4%)
Osteoporosis	1/69 (1.4%)
Fracture	1/69 (1.4%)
Extremity-Upper (Function)	1/69 (1.4%)
Gait/Walking	2/69 (2.9%)
Arthritis	5/69 (7.2%)
Muscle Weakness - Whole Body/Generalized	4/69 (5.8%)
Muscle Weakness - Left-Sided	1/69 (1.4%)
Muscle Weakness - Extremity-Lower	5/69 (7.2%)
Nervous system disorders
Pyramidal Tract Dysfunction	1/69 (1.4%)
Mood Alteration - Depression	23/69 (33.3%)
Mood Alteration - Anxiety	11/69 (15.9%)
Tremor	1/69 (1.4%)
Confusion	1/69 (1.4%)
Dizziness	9/69 (13%)
Neuropathy,cranial - Cn Xii Motor-Tongue	1/69 (1.4%)
Neuropathy,cranial - Cn Ix Motor-Pharynx	1/69 (1.4%)
Neuropathy-Sensory	25/69 (36.2%)
Neuropathy-Motor	1/69 (1.4%)
Renal and urinary disorders
Renal/Genitourinary - Other	2/69 (2.9%)
Leak, Gu - Vagina	1/69 (1.4%)
Cystitis	1/69 (1.4%)
Urinary Retention	1/69 (1.4%)
Obstruction, Gu - Ureter	4/69 (5.8%)
Incontinence, Urinary	2/69 (2.9%)
Fistula, Gu - Vagina	1/69 (1.4%)
Fistula, Gu - Bladder	2/69 (2.9%)
Bladder Spasm	2/69 (2.9%)
Renal Failure	1/69 (1.4%)
Urinary Frequency	7/69 (10.1%)
Reproductive system and breast disorders
Vaginal Discharge	2/69 (2.9%)
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other	2/69 (2.9%)
Airway Obstruction - Bronchus	1/69 (1.4%)
Nasal/Paranasal Reactions	2/69 (2.9%)
Voice Changes	1/69 (1.4%)
Hypoxia	1/69 (1.4%)
Cough	15/69 (21.7%)
Dyspnea	21/69 (30.4%)
Skin and subcutaneous tissue disorders
Nail Changes	2/69 (2.9%)
Hair Loss/Alopecia (Scalp Or Body)	14/69 (20.3%)
Wound Complication, Non-Infectious	1/69 (1.4%)
Acne	25/69 (36.2%)
Rash	38/69 (55.1%)
Dry Skin	11/69 (15.9%)
Decubitus	2/69 (2.9%)
Pruritus	7/69 (10.1%)
Burn	1/69 (1.4%)
Flushing	1/69 (1.4%)
Hand-Foot	6/69 (8.7%)
Vascular disorders
Inr	2/69 (2.9%)
Fibrinogen	2/69 (2.9%)
Ptt	3/69 (4.3%)
Hemorrhage, Gu - Urinary Nos	2/69 (2.9%)
Hemorrhage, Gu - Vagina	8/69 (11.6%)
Hemorrhage, Gi - Rectum	6/69 (8.7%)
Hemorrhage, Gu - Ovary	1/69 (1.4%)
Hemorrhage/Pulmonary - Nose	5/69 (7.2%)
Hemorrhage, Gi - Oral Cavity	1/69 (1.4%)
Hemorrhage, Gu - Bladder	4/69 (5.8%)
Hemorrhage, Gi - Abdomen Nos	1/69 (1.4%)
Petechiae	1/69 (1.4%)
Thrombosis/Thrombus/Embolism	6/69 (8.7%)
Phlebitis	1/69 (1.4%)

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.