Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma

• Sponsor: Eastern Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00068393
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 39
• Locations: 92
• Arm: 1
• Duration (Months): 89
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with gemcitabine works in treating patients with locally recurrent or metastatic unresectable renal cell carcinoma (kidney cancer).

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cell Carcinoma; Renal Cell Carcinoma With Sarcomatoid Features	Drug: Doxorubicin; Drug: Gemcitabine; Drug: G-CSF (granulocyte-colony stimulating factor); Drug: Neulasta	Phase 2

Detailed Description

OBJECTIVES:

• Determine the response rate of patients with locally recurrent or metastatic unresectable renal cell cancer with sarcomatoid features treated with doxorubicin and gemcitabine.

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

• Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin intravenously (IV) and gemcitabine IV over 30 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 2- or 3-10 or pegfilgrastim SC on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

After 6 courses, patients undergo a MUGA scan. Patients with a stable* left ventricular ejection fraction (LVEF) continue therapy as above. Patients who reach a total doxorubicin dose of 450 mg/m^2 and are found to have unstable cardiac function or who have an abnormal LVEF continue therapy with gemcitabine alone.

NOTE: *Stable cardiac function is defined as no decrease more than 15% of LVEF in absolute number and LVEF at least 35% in total function by MUGA.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

ACTUAL ACCRUAL: A total of 39 patients were accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Doxorubicin/Gemcitabine Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.

Drug: Doxorubicin; Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.; Other Names: Adriamycin Rubex ; Drug: Gemcitabine; Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.; Drug: G-CSF (granulocyte-colony stimulating factor); Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.; Other Names: Neupogen Filgrastim ; Drug: Neulasta; Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.; Other Names: pegfilgrastim

Outcome Measures

Primary Outcome Measures

1. Response Rate by Solid Tumor Response Criteria (RECIST) [Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry]

   Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

Secondary Outcome Measures

1. Overall Survival [Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry]

   Overall survival is defined as the time from study entry until death from any cause.

2. Progression-free Survival [Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry]

   Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

Eligibility Criteria

Criteria

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

INCLUSION CRITERIA:

• Histologically confirmed renal cell carcinoma

• Features must be of sarcomatoid histology

• Locally recurrent or metastatic disease not amenable to resection

• Measurable disease

• Must have a prior nephrectomy provided all other eligibility criteria are met, and adequately recovered from any recent surgery

• At least 4 weeks since prior radiotherapy and recovered

• ECOG performance status of 0-1

• WBC greater than 3,000/mm^{3 or absolute neutrophil count greater than 1,500/mm}3

• Platelet count greater than 100,000/mm^3

• Bilirubin less than 1.5 mg/dL

• Aspartate aminotransferase (AST) less than 2 times upper limit of normal

• Creatinine no greater than 2.0 mg/dL

• LVEF at least lower limit of normal by MUGA

• Negative pregnancy test

• Fertile patients must use effective contraception

• Other prior malignancy allowed provided patient was curatively treated and has been disease free from that cancer

• Age of 18 and over

• Diagnostic material from the kidney or metastatic site biopsy available for central pathologic review

EXCLUSION CRITERIA:

• Prior treatment for advanced disease

• Previously irradiated lesions as the sole site of disease for patients with prior radiation therapy

• Concurrent local radiotherapy for pain control or for life-threatening situations

• Myocardial infarction within the past year

• Congestive heart failure within the past year

• Significant ischemic or valvular heart disease within the past year

• Prior or concurrent brain metastases

• Concurrent serious medical illness that would preclude study treatment

• Active infection that would preclude study treatment

• Pregnant or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
2	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
3	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
4	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
5	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
6	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611
7	Mercy Hospital and Medical Center	Chicago	Illinois	United States	60616
8	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
9	Midwest Center for Hematology/Oncology	Joliet	Illinois	United States	60432
10	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
11	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
12	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois	United States	60714
13	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
14	Hematology/Oncology of the North Shore at Gross Point Medical Center	Skokie	Illinois	United States	60076
15	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
16	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
17	Elkhart General Hospital	Elkhart	Indiana	United States	46515
18	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
19	William N. Wishard Memorial Hospital	Indianapolis	Indiana	United States	46202
20	Howard Community Hospital at Howard Regional Health System	Kokomo	Indiana	United States	46904
21	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
22	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
23	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
24	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
25	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
26	McFarland Clinic, PC	Ames	Iowa	United States	50010
27	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
28	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
29	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
30	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
31	Cancer Research Center at Boston Medical Center	Boston	Massachusetts	United States	02118
32	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
33	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
34	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
35	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
36	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
37	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
38	Hurley Medical Center	Flint	Michigan	United States	48503
39	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
40	Foote Hospital	Jackson	Michigan	United States	49201
41	Borgess Medical Center	Kalamazooaa	Michigan	United States	49001
42	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
43	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
44	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48909
45	Seton Cancer Institute - Saginaw	Saginaw	Michigan	United States	48601
46	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	St. Joseph	Michigan	United States	49085
47	St. John Macomb Hospital	Warren	Michigan	United States	48093
48	CCOP - Duluth	Duluth	Minnesota	United States	55805
49	Miller-Dwan Medical Center	Duluth	Minnesota	United States	55805
50	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota	United States	55805
51	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
52	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
53	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
54	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
55	St. Vincent Healthcare	Billings	Montana	United States	59101
56	Billings Clinic Cancer Center	Billings	Montana	United States	59107-5100
57	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
58	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
59	St. James Community Hospital	Butte	Montana	United States	59701
60	Great Falls Clinic	Great Falls	Montana	United States	59405
61		Great Falls	Montana	United States	59405
62	St. Peter's Hospital	Helena	Montana	United States	59601
63	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
64	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
65	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
66	Community Medical Center	Missoula	Montana	United States	59801
67	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
68	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
69	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
70	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey	United States	08822
71	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
72	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
73	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York	United States	10466
74	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
75	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York	United States	13057
76	St. Rita's Medical Center	Lima	Ohio	United States	45801
77	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
78	Central Pennsylvania Hematology and Medical Oncology Associates, PC	Lemoyne	Pennsylvania	United States	17043
79	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
80	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
81	Mount Nittany Medical Center	State College	Pennsylvania	United States	16803
82	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
83	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
84	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57117-5039
85	Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital	Parkersburg	West Virginia	United States	26102
86	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
87	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
88	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
89	Aurora Sinai Medical Center	Milwaukee	Wisconsin	United States	53201-0342
90	Medical Consultants, Limited	Milwaukee	Wisconsin	United States	53215
91	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
92	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Eastern Cooperative Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Naomi S. Balzer-Haas, MD, Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT00068393
• Other Study ID Numbers: CDR0000322258; E8802; U10CA021115
• First Posted: Sep 11, 2003
• Last Update Posted: Jan 10, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Eastern Cooperative Oncology Group: Sarcomatoid; Gemcitabine; Doxorubicin; Renal cell cancer; Kidney cancer
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell; Gemcitabine; Doxorubicin; Lenograstim

Study Results

Participant Flow

Recruitment Details	The study was activated on December 9, 2003 and was closed to accrual on April 19, 2007. A total of 39 patients were registered to the study.

Arm/Group Title	Doxorubicin/Gemcitabine
Arm/Group Description	Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Period Title: Overall Study
STARTED	39
Eligible and Treated	38
COMPLETED	29
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Doxorubicin/Gemcitabine
Arm/Group Description	Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Overall Participants	38
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59
Sex: Female, Male (Count of Participants)
Female	8 21.1%
Male	30 78.9%
Region of Enrollment (participants) [Number]
United States	38 100%

Outcome Measures

1. Primary Outcome

Title	Response Rate by Solid Tumor Response Criteria (RECIST)
Description	Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR
Time Frame	Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Outcome Measure Data

Analysis Population Description

Only eligible and treated patients are included in this analysis.

Arm/Group Title	Doxorubicin/Gemcitabine
Arm/Group Description	Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Measure Participants	38
Number (90% Confidence Interval) [Percentage of Participants]	16 42.1%

2. Secondary Outcome

Title	Overall Survival
Description	Overall survival is defined as the time from study entry until death from any cause.
Time Frame	Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Outcome Measure Data

Analysis Population Description

Only eligible and treated patients are included in this analysis.

Arm/Group Title	Doxorubicin/Gemcitabine
Arm/Group Description	Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Measure Participants	38
Median (95% Confidence Interval) [Months]	8.8

3. Secondary Outcome

Title	Progression-free Survival
Description	Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.
Time Frame	Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Outcome Measure Data

Analysis Population Description

Only eligible and treated patients are included in this analysis.

Arm/Group Title	Doxorubicin/Gemcitabine
Arm/Group Description	Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Measure Participants	38
Median (95% Confidence Interval) [Months]	3.5

Adverse Events

Time Frame	Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Arm/Group Title	Doxorubicin/Gemcitabine
Arm/Group Description	Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
All Cause Mortality
	Doxorubicin/Gemcitabine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Doxorubicin/Gemcitabine
	Affected / at Risk (%)	# Events
Total	15/38 (39.5%)
Blood and lymphatic system disorders
Anemia	5/38 (13.2%)
Febrile neutropenia	1/38 (2.6%)
Cardiac disorders
Atrial fibrillation	1/38 (2.6%)
Sinus tachycardia	1/38 (2.6%)
Left ventricular systolic dysfunction	1/38 (2.6%)
Gastrointestinal disorders
Diarrhea w/o prior colostomy	1/38 (2.6%)
Dysphagia	1/38 (2.6%)
Muco/stomatitis by exam, oral cavity	2/38 (5.3%)
Nausea	1/38 (2.6%)
General disorders
Fatigue	3/38 (7.9%)
Death - multiorgan failure	1/38 (2.6%)
Infections and infestations
Infection w/ Gr0-2 neutropenia, lung	1/38 (2.6%)
Infection w/ unknown ANC peristomal	1/38 (2.6%)
Infection w/ unknown ANC upper airway NOS	1/38 (2.6%)
Infection w/ unknown ANC urinary tract NOS	1/38 (2.6%)
Investigations
Leukopenia	4/38 (10.5%)
Neutropenia	7/38 (18.4%)
Thrombocytopenia	1/38 (2.6%)
Musculoskeletal and connective tissue disorders
Chest wall, pain	1/38 (2.6%)
Respiratory, thoracic and mediastinal disorders
Cough	1/38 (2.6%)
Dyspnea	3/38 (7.9%)
Other (Not Including Serious) Adverse Events
	Doxorubicin/Gemcitabine
	Affected / at Risk (%)	# Events
Total	38/38 (100%)
Blood and lymphatic system disorders
Anemia	32/38 (84.2%)
Cardiac disorders
Left ventricular systolic dysfunction	2/38 (5.3%)
Gastrointestinal disorders
Constipation	15/38 (39.5%)
Diarrhea w/o prior colostomy	7/38 (18.4%)
Dry mouth	4/38 (10.5%)
Dyspepsia	3/38 (7.9%)
Muco/stomatitis by exam, oral cavity	8/38 (21.1%)
Nausea	22/38 (57.9%)
Vomiting	9/38 (23.7%)
General disorders
Fatigue	27/38 (71.1%)
Fever w/o neutropenia	4/38 (10.5%)
Edema: limb	6/38 (15.8%)
Investigations
Leukopenia	7/38 (18.4%)
Lymphopenia	2/38 (5.3%)
Neutropenia	3/38 (7.9%)
Thrombocytopenia	7/38 (18.4%)
Weight loss	2/38 (5.3%)
Alkaline phosphatase increased	4/38 (10.5%)
AST increased	8/38 (21.1%)
Bilirubin increased	2/38 (5.3%)
Creatinine increased	16/38 (42.1%)
Metabolism and nutrition disorders
Anorexia	15/38 (39.5%)
Dehydration	2/38 (5.3%)
Hyperglycemia	4/38 (10.5%)
Hyponatremia	2/38 (5.3%)
Musculoskeletal and connective tissue disorders
Back, pain	2/38 (5.3%)
Joint, pain	2/38 (5.3%)
Muscle, pain	8/38 (21.1%)
Nervous system disorders
Taste disturbance	3/38 (7.9%)
Neuropathy-sensory	4/38 (10.5%)
Head/headache	3/38 (7.9%)
Psychiatric disorders
Anxiety	2/38 (5.3%)
Depression	2/38 (5.3%)
Respiratory, thoracic and mediastinal disorders
Cough	5/38 (13.2%)
Dyspnea	8/38 (21.1%)
Skin and subcutaneous tissue disorders
Dry skin	5/38 (13.2%)
Alopecia	22/38 (57.9%)
Nail changes	4/38 (10.5%)
Rash/desquamation	6/38 (15.8%)
Vascular disorders
Phlebitis	2/38 (5.3%)

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.