Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

• Sponsor: Gynecologic Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00114166
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 81
• Locations: 78
• Arms: 2
• Patients Per Site: 1

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.

PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer	Drug: topotecan hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer.

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

Secondary

• Determine the duration of progression-free survival and overall survival in patients treated with these regimens.

• Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy	Drug: topotecan hydrochloride
Active Comparator: Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy	Drug: topotecan hydrochloride

Outcome Measures

Primary Outcome Measures

1. Objective Tumor Response [Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal]

   Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is 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) is 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. Disease Progression is 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 is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.

2. Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0 [Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up]

Secondary Outcome Measures

1. Reason Off Study Therapy [study entry through end of study treatment, up to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer

• Recurrent disease

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• At least 1 target lesion not in a previously irradiated field

• Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound

• Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment

• Patients who have not received prior paclitaxel may receive a second regimen that includes paclitaxel

• Platinum-sensitive disease

• Treatment-free interval* without clinical evidence of progressive disease for > 6 months after prior response to a platinum-based regimen NOTE: *Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval

• Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

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

• Platelet count ≥ 100,000/mm^3

Hepatic

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

• SGOT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

• Creatinine clearance > 40 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No sensory or motor neuropathy > grade 1

• No active infection requiring antibiotics

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 weeks since prior biologic or immunologic agents for the malignancy

• No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease

• No concurrent cytokines during the first course of study treatment

• No concurrent pegfilgrastim

Chemotherapy

• See Disease Characteristics

• See Biologic therapy

• Recovered from prior chemotherapy

• No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen

• No prior topotecan

Endocrine therapy

• At least 1 week since prior hormonal therapy for the malignancy

• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics

• Recovered from prior radiotherapy

• No prior radiotherapy to > 25% of marrow-bearing areas

Surgery

• Recovered from prior surgery

Other

• At least 3 weeks since other prior therapy for the malignancy

• No prior anticancer therapy that would preclude study treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
2	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut	United States	06050
3	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
4	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
5	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia	United States	20010
6	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912
7	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
8	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
9	Rush University Medical Center	Chicago	Illinois	United States	60612
10	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
11	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
12	Advocate Lutheran General Cancer Care Center	Park Ridge	Illinois	United States	60068-1174
13	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
14	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
15	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
16	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
17	Woman's Hospital	Baton Rouge	Louisiana	United States	70815
18	Union Hospital Cancer Program at Union Hospital	Elkton	Maryland	United States	21921
19	Tufts-NEMC Cancer Center	Boston	Massachusetts	United States	02111
20	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts	United States	01655
21	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
22	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
23	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
24	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
25	Hurley Medical Center	Flint	Michigan	United States	48503
26	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
27	Foote Memorial Hospital	Jackson	Michigan	United States	49201
28	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
29	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
30	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
31	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
32	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
33	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
34	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
35	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
36	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
37	St. John Macomb Hospital	Warren	Michigan	United States	48093
38	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
39	Saint Louis University Cancer Center	Saint Louis	Missouri	United States	63110
40	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
41	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
42	St. John's Regional Health Center	Springfield	Missouri	United States	65804
43	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
44	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
45	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
46	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
47	Jersey Shore Cancer Center at Jersey Shore University Medical Center	Neptune	New Jersey	United States	07754-0397
48	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
49	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
50	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York	United States	10032
51	Stony Brook University Cancer Center	Stony Brook	New York	United States	11794-9446
52	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
53	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
54	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
55	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
56	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
57	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio	United States	44111
58	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
59	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
60	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
61	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio	United States	44124
62	Lake/University Ireland Cancer Center	Mentor	Ohio	United States	44060
63	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
64	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma	United States	74104
65	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
66	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
67	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
68	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
69	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
70	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052
71	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
72	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
73	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
74	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
75	Harrington Cancer Center	Amarillo	Texas	United States	79106
76	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
77	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
78	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476

Sponsors and Collaborators

• Gynecologic Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Thomas J. Herzog, MD, Herbert Irving Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00114166
• Other Study ID Numbers: GOG-0146Q; GOG-0146Q; CDR0000434848
• First Posted: Jun 14, 2005
• Last Update Posted: Jul 24, 2018
• Last Verified: May 1, 2014

• Keywords provided by Gynecologic Oncology Group: recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer
• Additional relevant MeSH terms: Fallopian Tube Neoplasms; Topotecan

Study Results

Participant Flow

Recruitment Details	Regimen 1 (Topotecan 1.25 mg/m2) recruitment ended early due to lack of interest by institutions.

Arm/Group Title	Regimen I (Topotecan 1.25 mg/m2)	Regimen II (Topotecan 4.0 mg/m2 )
Arm/Group Description	Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy	Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
Period Title: Overall Study
STARTED	15	66
COMPLETED	15	65
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Regimen I (Topotecan 1.25 mg/m2)	Regimen II (Topotecan 4.0 mg/m2)	Total
Arm/Group Description	Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy	Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy	Total of all reporting groups
Overall Participants	15	65	80
Age, Customized (Count of Participants)
40-49 years	2 13.3%	5 7.7%	7 8.8%
50-59 years	3 20%	29 44.6%	32 40%
60-69 years	4 26.7%	17 26.2%	21 26.3%
70-79 years	5 33.3%	12 18.5%	17 21.3%
> 79 years	1 6.7%	2 3.1%	3 3.8%
Sex: Female, Male (Count of Participants)
Female	15 100%	65 100%	80 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	65 100%	80 100%
Cell Type (participants) [Number]
Adenocarcinoma, Unspecified	0 0%	5 7.7%	5 6.3%
Clear Cell Carcinoma	1 6.7%	1 1.5%	2 2.5%
Endometrioid Adenocarcinoma	0 0%	2 3.1%	2 2.5%
Mixed Epithelial Carcinoma	1 6.7%	5 7.7%	6 7.5%
Undifferentiated Carcinoma	0 0%	1 1.5%	1 1.3%
Serous Adenocarcinoma	13 86.7%	50 76.9%	63 78.8%
Other Carcinoma	0 0%	1 1.5%	1 1.3%

Outcome Measures

1. Primary Outcome

Title	Objective Tumor Response
Description	Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is 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) is 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. Disease Progression is 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 is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Time Frame	Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants

Arm/Group Title	Regimen I (Topotecan 1.25 mg/m2)	Regimen II (Topotecan 4.0 mg/m2)
Arm/Group Description	Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy	Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
Measure Participants	15	65
Partial Response	4 26.7%	8 12.3%
Stable Disease	8 53.3%	32 49.2%
Increase Disease	2 13.3%	21 32.3%
Indeterminate	1 6.7%	4 6.2%

2. Primary Outcome

Title	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Time Frame	Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Outcome Measure Data

Analysis Population Description

Eligible and treated patients

Arm/Group Title	Regimen I	Regimen II
Arm/Group Description	Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy	Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
Measure Participants	15	65
Leukopenia	10 66.7%	6 9.2%
Thrombocytopenia	7 46.7%	6 9.2%
Neutropenia	14 93.3%	18 27.7%
Anemia	5 33.3%	9 13.8%
Nausea/vomiting	1 6.7%	1 1.5%
Other Gastrointestinal	1 6.7%	0 0%
Neurologic	0 0%	1 1.5%
Constitutional	1 6.7%	2 3.1%
Cardiovascular	1 6.7%	0 0%
Infection	1 6.7%	2 3.1%
Musculoskeletal	0 0%	1 1.5%
Pulmonary	1 6.7%	2 3.1%
Pain	0 0%	4 6.2%

3. Secondary Outcome

Title	Reason Off Study Therapy
Time Frame	study entry through end of study treatment, up to 5 years

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants

Arm/Group Title	Regimen I (Topotecan 1.25 mg/m2)	Regimen II (Topotecan 4.0 mg/m2)
Arm/Group Description	Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy	Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
Measure Participants	15	65
Disease Progression	9 60%	47 72.3%
Refused further treatment	3 20%	7 10.8%
Toxicity as permitted	3 20%	2 3.1%
Other	0 0%	9 13.8%

Adverse Events

Time Frame	All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
Arm/Group Title	Regimen I		Regimen II
Arm/Group Description	Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy		Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
All Cause Mortality
	Regimen I		Regimen II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Regimen I		Regimen II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/15 (53.3%)		10/65 (15.4%)
Blood and lymphatic system disorders
Neutrophils	1/15 (6.7%)		0/65 (0%)
Hemoglobin	0/15 (0%)		1/65 (1.5%)
Gastrointestinal disorders
Obstruction, Gi - Cecum	1/15 (6.7%)		0/65 (0%)
Obstruction, Gi - Small Bowel Nos	1/15 (6.7%)		1/65 (1.5%)
Vomiting	1/15 (6.7%)		1/65 (1.5%)
Dehydration	1/15 (6.7%)		0/65 (0%)
Nausea	1/15 (6.7%)		0/65 (0%)
Diarrhea	0/15 (0%)		1/65 (1.5%)
General disorders
Pain: Back	1/15 (6.7%)		0/65 (0%)
Pain: Abdominal Pain Nos	1/15 (6.7%)		0/65 (0%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos	1/15 (6.7%)		0/65 (0%)
Inf W/Gr 3 Or 4 Anc: Bronchus	1/15 (6.7%)		0/65 (0%)
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney	1/15 (6.7%)		1/65 (1.5%)
Metabolism and nutrition disorders
Hyponatremia	0/15 (0%)		1/65 (1.5%)
Nervous system disorders
Mood Alteration - Depression	0/15 (0%)		1/65 (1.5%)
Renal and urinary disorders
Renal Failure	0/15 (0%)		1/65 (1.5%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	0/15 (0%)		1/65 (1.5%)
Hypoxia	0/15 (0%)		1/65 (1.5%)
Dyspnea	0/15 (0%)		1/65 (1.5%)
Vascular disorders
Thrombosis/Thrombus/Embolism	1/15 (6.7%)		0/65 (0%)
Other (Not Including Serious) Adverse Events
	Regimen I		Regimen II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/15 (66.7%)		60/65 (92.3%)
Blood and lymphatic system disorders
Neutrophils	9/15 (60%)		44/65 (67.7%)
Platelets	8/15 (53.3%)		38/65 (58.5%)
Leukocytes	8/15 (53.3%)		47/65 (72.3%)
Lymphopenia	0/15 (0%)		1/65 (1.5%)
Hemoglobin	8/15 (53.3%)		58/65 (89.2%)
Edema: Trunk/Genital	0/15 (0%)		1/65 (1.5%)
Edema: Limb	2/15 (13.3%)		11/65 (16.9%)
Edema: Head And Neck	1/15 (6.7%)		0/65 (0%)
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation	0/15 (0%)		1/65 (1.5%)
Palpitations	0/15 (0%)		2/65 (3.1%)
Ventricular Arrhythmia - Tachycardia	0/15 (0%)		1/65 (1.5%)
S/N Arrhythmia: Sinus Tachycardia	0/15 (0%)		3/65 (4.6%)
S/N Arrhythmia: Atrial Tachycardia	0/15 (0%)		1/65 (1.5%)
Hypertension	0/15 (0%)		7/65 (10.8%)
Hypotension	0/15 (0%)		3/65 (4.6%)
Ear and labyrinth disorders
Hearing (Without Monitoring Program)	0/15 (0%)		2/65 (3.1%)
Tinnitus	0/15 (0%)		2/65 (3.1%)
Endocrine disorders
Hot Flashes	0/15 (0%)		3/65 (4.6%)
Diabetes	0/15 (0%)		3/65 (4.6%)
Eye disorders
Ocular/Visual - Other	0/15 (0%)		2/65 (3.1%)
Watery Eye	0/15 (0%)		1/65 (1.5%)
Cataract	1/15 (6.7%)		0/65 (0%)
Blurred Vision	2/15 (13.3%)		4/65 (6.2%)
Gastrointestinal disorders
Flatulence	0/15 (0%)		2/65 (3.1%)
Gastritis	0/15 (0%)		1/65 (1.5%)
Heartburn	2/15 (13.3%)		8/65 (12.3%)
Ulcer,gi - Stomach	0/15 (0%)		1/65 (1.5%)
Ascites	1/15 (6.7%)		3/65 (4.6%)
Dysphagia	1/15 (6.7%)		0/65 (0%)
Distention	2/15 (13.3%)		4/65 (6.2%)
Taste Alteration	0/15 (0%)		7/65 (10.8%)
Incontinence, Anal	0/15 (0%)		1/65 (1.5%)
Mucositis (Functional/Sympt) - Oral Cavity	2/15 (13.3%)		2/65 (3.1%)
Colitis	1/15 (6.7%)		0/65 (0%)
Mucositis (Clinical Exam) - Oral Cavity	0/15 (0%)		5/65 (7.7%)
Vomiting	4/15 (26.7%)		12/65 (18.5%)
Anorexia	2/15 (13.3%)		16/65 (24.6%)
Dehydration	1/15 (6.7%)		4/65 (6.2%)
Constipation	5/15 (33.3%)		29/65 (44.6%)
Nausea	7/15 (46.7%)		39/65 (60%)
Gastrointestinal - Other	0/15 (0%)		1/65 (1.5%)
Diarrhea	4/15 (26.7%)		10/65 (15.4%)
General disorders
Sweating	1/15 (6.7%)		5/65 (7.7%)
Weight Gain	0/15 (0%)		3/65 (4.6%)
Fever	1/15 (6.7%)		9/65 (13.8%)
Weight Loss	0/15 (0%)		3/65 (4.6%)
Rigors/Chills	0/15 (0%)		5/65 (7.7%)
Fatigue	8/15 (53.3%)		46/65 (70.8%)
Insomnia	2/15 (13.3%)		14/65 (21.5%)
Pain - Other	1/15 (6.7%)		4/65 (6.2%)
Pain: Urethra	0/15 (0%)		1/65 (1.5%)
Pain: Pelvis	0/15 (0%)		3/65 (4.6%)
Pain: Chest /Thorax Nos	1/15 (6.7%)		5/65 (7.7%)
Pain: Chest Wall	1/15 (6.7%)		1/65 (1.5%)
Pain: Throat/Pharynx/Larynx	0/15 (0%)		2/65 (3.1%)
Pain: Head/Headache	1/15 (6.7%)		11/65 (16.9%)
Pain: Neck	0/15 (0%)		1/65 (1.5%)
Pain: Extremity-Limb	0/15 (0%)		10/65 (15.4%)
Pain: Back	2/15 (13.3%)		9/65 (13.8%)
Pain: Joint	0/15 (0%)		5/65 (7.7%)
Pain: Bone	0/15 (0%)		2/65 (3.1%)
Pain: Lymph Node	0/15 (0%)		1/65 (1.5%)
Pain: Kidney	1/15 (6.7%)		0/65 (0%)
Pain: Pain Nos	0/15 (0%)		1/65 (1.5%)
Pain: Oral Cavity	0/15 (0%)		1/65 (1.5%)
Pain: Dental/Teeth/Peridontal	0/15 (0%)		2/65 (3.1%)
Pain: Abdominal Pain Nos	3/15 (20%)		16/65 (24.6%)
Pain: Tumor	0/15 (0%)		1/65 (1.5%)
Pain: Muscle	1/15 (6.7%)		2/65 (3.1%)
Immune system disorders
Allergic Reaction/Hypersensitivity	0/15 (0%)		3/65 (4.6%)
Rhinitis	0/15 (0%)		3/65 (4.6%)
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	0/15 (0%)		3/65 (4.6%)
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	0/15 (0%)		1/65 (1.5%)
Inf Unknown Anc: Sinus	0/15 (0%)		1/65 (1.5%)
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth	0/15 (0%)		1/65 (1.5%)
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	0/15 (0%)		4/65 (6.2%)
Infection - Other	0/15 (0%)		1/65 (1.5%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus	0/15 (0%)		1/65 (1.5%)
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	0/15 (0%)		2/65 (3.1%)
Inf Unknown Anc: Bronchus	0/15 (0%)		1/65 (1.5%)
Inf Unknown Anc: Urinary Tract Nos	0/15 (0%)		3/65 (4.6%)
Inf Unknown Anc: Catheter-Related	0/15 (0%)		1/65 (1.5%)
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	0/15 (0%)		1/65 (1.5%)
Metabolism and nutrition disorders
Ast	0/15 (0%)		9/65 (13.8%)
Gfr	0/15 (0%)		2/65 (3.1%)
Metabolic/Laboratory - Other	0/15 (0%)		2/65 (3.1%)
Cholesterol,serum High	0/15 (0%)		1/65 (1.5%)
Proteinuria	0/15 (0%)		1/65 (1.5%)
Creatinine	1/15 (6.7%)		6/65 (9.2%)
Hypoalbuminemia	2/15 (13.3%)		3/65 (4.6%)
Alt	1/15 (6.7%)		8/65 (12.3%)
Alkaline Phosphatase	2/15 (13.3%)		8/65 (12.3%)
Bilirubin	1/15 (6.7%)		1/65 (1.5%)
Hypermagnesemia	0/15 (0%)		1/65 (1.5%)
Hypophosphatemia	1/15 (6.7%)		3/65 (4.6%)
Hyponatremia	2/15 (13.3%)		5/65 (7.7%)
Hypertriglyceridemia	0/15 (0%)		2/65 (3.1%)
Bicarbonate, Serum-Low	0/15 (0%)		3/65 (4.6%)
Hypernatremia	1/15 (6.7%)		2/65 (3.1%)
Hypocalcemia	2/15 (13.3%)		6/65 (9.2%)
Hyperkalemia	2/15 (13.3%)		1/65 (1.5%)
Hyperglycemia	4/15 (26.7%)		20/65 (30.8%)
Hypokalemia	1/15 (6.7%)		11/65 (16.9%)
Hypoglycemia	0/15 (0%)		1/65 (1.5%)
Hypercalcemia	0/15 (0%)		1/65 (1.5%)
Hypomagnesemia	5/15 (33.3%)		10/65 (15.4%)
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other	0/15 (0%)		1/65 (1.5%)
Osteoporosis	1/15 (6.7%)		0/65 (0%)
Joint-Function	0/15 (0%)		1/65 (1.5%)
Fracture	1/15 (6.7%)		0/65 (0%)
Arthritis	0/15 (0%)		6/65 (9.2%)
Muscle Weakness - Whole Body/Generalized	0/15 (0%)		5/65 (7.7%)
Muscle Weakness - Extremity-Upper	0/15 (0%)		1/65 (1.5%)
Muscle Weakness - Extremity-Lower	1/15 (6.7%)		1/65 (1.5%)
Nervous system disorders
Syncope	0/15 (0%)		1/65 (1.5%)
Involuntary Movement	0/15 (0%)		1/65 (1.5%)
Mood Alteration - Depression	2/15 (13.3%)		8/65 (12.3%)
Mood Alteration - Anxiety	0/15 (0%)		7/65 (10.8%)
Mood Alteration - Agitation	0/15 (0%)		1/65 (1.5%)
Speech Impairment	0/15 (0%)		1/65 (1.5%)
Cognitive Disturbance	0/15 (0%)		1/65 (1.5%)
Ataxia	0/15 (0%)		1/65 (1.5%)
Confusion	0/15 (0%)		2/65 (3.1%)
Memory Impairment	0/15 (0%)		4/65 (6.2%)
Dizziness	2/15 (13.3%)		8/65 (12.3%)
Neuropathy-Sensory	3/15 (20%)		26/65 (40%)
Neuropathy-Motor	0/15 (0%)		3/65 (4.6%)
Renal and urinary disorders
Cystitis	0/15 (0%)		3/65 (4.6%)
Urinary Retention	0/15 (0%)		2/65 (3.1%)
Obstruction, Gu - Ureter	0/15 (0%)		1/65 (1.5%)
Incontinence, Urinary	0/15 (0%)		2/65 (3.1%)
Bladder Spasm	0/15 (0%)		1/65 (1.5%)
Urinary Frequency	2/15 (13.3%)		1/65 (1.5%)
Reproductive system and breast disorders
Libido	0/15 (0%)		1/65 (1.5%)
Vaginal Discharge	0/15 (0%)		1/65 (1.5%)
Respiratory, thoracic and mediastinal disorders
Chylothorax	0/15 (0%)		1/65 (1.5%)
Voice Changes	0/15 (0%)		1/65 (1.5%)
Hypoxia	1/15 (6.7%)		1/65 (1.5%)
Cough	3/15 (20%)		13/65 (20%)
Pleural Effusion	0/15 (0%)		1/65 (1.5%)
Dyspnea	3/15 (20%)		21/65 (32.3%)
Skin and subcutaneous tissue disorders
Nail Changes	0/15 (0%)		1/65 (1.5%)
Hair Loss/Alopecia (Scalp Or Body)	5/15 (33.3%)		19/65 (29.2%)
Bruising	0/15 (0%)		5/65 (7.7%)
Acne	0/15 (0%)		1/65 (1.5%)
Rash	1/15 (6.7%)		4/65 (6.2%)
Dry Skin	0/15 (0%)		3/65 (4.6%)
Pruritus	0/15 (0%)		1/65 (1.5%)
Flushing	1/15 (6.7%)		1/65 (1.5%)
Hand-Foot	0/15 (0%)		1/65 (1.5%)
Vascular disorders
Inr	0/15 (0%)		1/65 (1.5%)
Ptt	0/15 (0%)		2/65 (3.1%)
Hemorrhage, Gu - Urinary Nos	0/15 (0%)		1/65 (1.5%)
Hemorrhage/Pulmonary - Nose	0/15 (0%)		2/65 (3.1%)
Hemorrhage, Gi - Anus	0/15 (0%)		1/65 (1.5%)
Hemorrhage, Gi - Oral Cavity	0/15 (0%)		1/65 (1.5%)
Petechiae	0/15 (0%)		1/65 (1.5%)
Thrombosis/Thrombus/Embolism	1/15 (6.7%)		1/65 (1.5%)

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.