ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00110084
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 50
• Locations: 201
• Arm: 1
• Duration (Months): 60
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Gemcitabine; Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer.

• Determine the toxicity profile of this regimen, in terms of incidence and severity of observed toxic effects, in these patients.

Secondary

• Determine the time to disease progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nab-paclitaxel/Gemcitabine	Drug: Gemcitabine; 1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle; Other Names: Gemzar ; Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound); 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle; Other Names: nab (nanoparticle albumin-bound)-Paclitaxel, Abraxane

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients With Confirmed Responses [Two consecutive evaluations at least 6 weeks apart]

   Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.

Secondary Outcome Measures

1. Progression-free Survival [Time from registration to progression or death (up to 5 years)]

   Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.

2. Overall Survival [Death or last follow-up (up to 5 years)]

   Overall survival time was defined as the number of days from registration to the date of death or last follow-up

3. Adverse Event [Every 6 weeks]

   Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0

Eligibility Criteria

Criteria

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

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed invasive breast cancer

• Clinical evidence of metastatic disease

• No bone metastases or other non-measurable disease as the only evidence of metastasis

• Measurable disease, defined as at least 1 measurable lesion

• The following are considered non-measurable disease:

• Small lesions (< 2 cm)

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural or pericardial effusions

• Inflammatory breast disease

• Lymphangitis cutis or pulmonis

• Abdominal masses that are not confirmed and followed by imaging techniques

• Cystic lesions

• HER2(human epidermal growth factor receptor 2)-positive disease allowed provided patient has received prior treatment with trastuzumab

• No evidence of active brain metastasis, including leptomeningeal involvement

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over Sex

• Female Menopausal status

• Not specified Performance status

• ECOG 0-1 Life expectancy

• At least 12 weeks Hematopoietic

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

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9 g/dL Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN Renal

• Creatinine ≤ 1.5 mg/dL Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 30 days after completion of study treatment

• No pre-existing peripheral neuropathy > grade 1

• No other clinically significant illness or significant medical condition that would preclude study participation

• No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or agents that are chemically similar to study drugs

• No serious medical risk factors involving any of the major organ systems that would preclude study participation

• No active stage III or IV invasive non-breast malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics Chemotherapy

• No more than 1 prior adjuvant chemotherapy regimen

• No prior chemotherapy for metastatic disease

• At least 6 months since prior adjuvant or neoadjuvant taxane

• More than 2 weeks since prior cytotoxic chemotherapy

• Prior neoadjuvant chemotherapy allowed

• No other concurrent chemotherapy Endocrine therapy

• Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed Radiotherapy

• Prior radiotherapy to target lesion allowed provided there is evidence of disease progression after completion of treatment

• More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target lesion only or single-dose palliative radiotherapy

• No concurrent radiotherapy Surgery

• Not specified Other

• More than 2 weeks since prior investigational drugs

• No concurrent participation in another clinical trial that is studying investigational procedures or therapies

• Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation of pain or lytic lesions from breast cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36652-2144
2	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
3	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
4	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
5	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
6	Porter Adventist Hospital	Denver	Colorado	United States	80210
7	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
8	St. Joseph Hospital	Denver	Colorado	United States	80218
9	Rose Medical Center	Denver	Colorado	United States	80220
10	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224-2522
11	Swedish Medical Center	Englewood	Colorado	United States	80110
12	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
13	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80502
14	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
15	North Suburban Medical Center	Thorton	Colorado	United States	80229
16	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224
17	Piedmont Hospital	Atlanta	Georgia	United States	30309
18	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342-1611
19	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342-1701
20	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
21	WellStar Cobb Hospital	Austell	Georgia	United States	30106
22	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
23	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
24	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
25	Southern Regional Medical Center	Riverdale	Georgia	United States	30274-2600
26	Kapiolani Medical Center at Pali Momi	Aiea	Hawaii	United States	96701
27	Cancer Research Center of Hawaii	Honolula	Hawaii	United States	96813
28	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii	United States	96813
29	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii	United States	96813
30	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
31	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817
32	St. Francis Medical Center	Honolulu	Hawaii	United States	96817
33	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
34	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
35	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
36	Graham Hospital	Canton	Illinois	United States	61520
37	Memorial Hospital	Carthage	Illinois	United States	62321
38	Eureka Community Hospital	Eureka	Illinois	United States	61530
39	Galesburg Clinic	Galesburg	Illinois	United States	61401
40	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
41	Mason District Hospital	Havana	Illinois	United States	62644
42	Hopedale Medical Complex	Hopedale	Illinois	United States	61747
43	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
44	Kewanee Hospital	Kewanee	Illinois	United States	61443
45	McDonough District Hospital	Macomb	Illinois	United States	61455
46	Trinity Medical Center - East	Moline	Illinois	United States	61265
47		Moline	Illinois	United States	61265
48	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
49	Community Cancer Center	Normal	Illinois	United States	61761
50	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
51	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
52	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
53	Proctor Hospital	Peoria	Illinois	United States	61614
54	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
55	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
56	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
57	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
58	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
59	Perry Memorial Hospital	Princeton	Illinois	United States	61356
60	St. Margaret's Hospital	Spring Valley	Illinois	United States	61362
61	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
62	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
63	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
64	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
65	McFarland Clinic, P. C.	Ames	Iowa	United States	50010
66		Bettendorf	Iowa	United States	52722
67	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
68	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
69	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
70	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
71	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
72	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
73	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
74	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
75	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
76	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
77	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
78	Ottumwa Regional Health Center Cancer Center	Ottumwa	Iowa	United States	52501
79	Siouxland Hematology-Oncology Associates	Sioux City	Iowa	United States	51101
80	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
81	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
82	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
83	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa	United States	50266
84	Cancer Center of Kansas, P.A. - Chanute	Chanute	Kansas	United States	66720
85	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
86	Cancer Center of Kansas, P.A. - El Dorado	El Dorado	Kansas	United States	67042
87	Cancer Center of Kansas, P.A. - Kingman	Kingman	Kansas	United States	67068
88	Southwest Medical Center	Liberal	Kansas	United States	67901
89	Cancer Center of Kansas, P.A. - Newton	Newton	Kansas	United States	67114
90	Cancer Center of Kansas, P.A. - Parsons	Parsons	Kansas	United States	67357
91	Cancer Center of Kansas, P.A. - Pratt	Pratt	Kansas	United States	67124
92	Cancer Center of Kansas, P.A. - Salina	Salina	Kansas	United States	67042
93	Cancer Center of Kansas, P.A. - Wellington	Wellington	Kansas	United States	67152
94	Associates in Womens Health, P.A. - North Review	Wichita	Kansas	United States	67203
95	Cancer Center of Kansas, P.A. - Medical Arts Tower	Wichita	Kansas	United States	67208
96	Cancer Center of Kansas, P.A. - Wichita	Wichita	Kansas	United States	67214
97	CCOP - Wichita	Wichita	Kansas	United States	67214
98	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
99	Cancer Center of Kansas, P.A. - Winfield	Winfield	Kansas	United States	67156
100	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
101	St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
102	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
103	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
104	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
105	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
106	Green Bay Oncology, Limited - Iron Mountain	Iron Mountain	Michigan	United States	49801
107	Haematology-Oncology Associates of Ohio and Michigan, P.C.	Lambertville	Michigan	United States	48144
108	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
109	Mercy Memorial Hospital System	Monroe	Michigan	United States	48162
110	Seton Cancer Institute - Saginaw	Saginaw	Michigan	United States	48601
111	St. John Macomb Hospital	Warren	Michigan	United States	48093
112		Alexandria	Minnesota	United States	56308
113	MeritCare Clinic - Bemidji	Bemidji	Minnesota	United States	56601
114	Brainerd Medical Center	Brainerd	Minnesota	United States	56401
115	St. Joseph's Medical Center	Brainerd	Minnesota	United States	56401
116	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
117	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
118	CCOP - Duluth	Duluth	Minnesota	United States	55805
119	Miller-Dwan Medical Center	Duluth	Minnesota	United States	55805
120	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota	United States	55805
121	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
122		Fergus Falls	Minnesota	United States	56537
123	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
124	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
125	Meeker County Memorial Hospital	Lichfield	Minnesota	United States	55355
126	Immanuel St. Joseph's Clinic	Mankato	Minnesota	United States	56002
127	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
128	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
129	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
130	Chippewa County - Montevideo Hospital	Montevideo	Minnesota	United States	56265
131	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota	United States	55422-2900
132	Mayo Clinic	Rochester	Minnesota	United States	55905
133	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
134	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
135	Saint Francis Cancer Center	Shakopee	Minnesota	United States	55379
136	St. Joseph's Hospital	St Paul	Minnesota	United States	55102
137	CentraCare Clinic - River Campus	St. Cloud	Minnesota	United States	56303
138	Park Nicollet Health Services	St. Louis Park	Minnesota	United States	55416
139	Regions Hospital Cancer Care Center	St. Paul	Minnesota	United States	55101
140	United Hospital	St. Paul	Minnesota	United States	55102
141	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
142	Woodwinds Health Campus	Woodbury	Minnesota	United States	55125
143	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
144	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
145	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
146	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
147	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota	United States	58501
148	Mid Dakota Clinic, P. C.	Bismarck	North Dakota	United States	58501
149	St. Alexius Medical Center	Bismarck	North Dakota	United States	58502
150	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
151	MeritCare Medical Group	Fargo	North Dakota	United States	58122
152	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota	United States	58201
153	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
154	Grandview Hospital	Dayton	Ohio	United States	45405
155	Good Samaritan Hospital	Dayton	Ohio	United States	45406
156	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
157	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
158	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
159	CCOP - Dayton	Dayton	Ohio	United States	45429
160	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
161	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
162	Kenton Oncology, Incorporated	Kenton	Ohio	United States	43326
163	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
164	Lima Memorial Hospital	Lima	Ohio	United States	45804
165	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537
166	St. Luke's Hospital	Maumee	Ohio	United States	43537
167	Middletown Regional Hospital	Middletown	Ohio	United States	45044
168	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
169	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
170	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
171	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
172	Promedica Cancer Center at Flower Hospital	Sylvania	Ohio	United States	43560
173	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
174	Toledo Hospital	Toledo	Ohio	United States	43606
175	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
176	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
177	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623
178	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
179	Toledo Surgical Specialists	Toledo	Ohio	United States	43623
180	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
181	Fulton County Health Center	Wauseon	Ohio	United States	43567
182	United States Air Force Medical Center Wright-Patterson	Wright-Patterson Afb	Ohio	United States	45433-5529
183	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
184	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
185	Geisinger Medical Center	Danville	Pennsylvania	United States	17822-0001
186	Geisinger Medical Group	State College	Pennsylvania	United States	16801
187	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
188	Rose Ramer Cancer Clinic at Anderson Area Medical Center	Anderson	South Carolina	United States	29621
189	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
190	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
191	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
192	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
193	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
194	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57117-5039
195	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
196	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
197	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
198	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
199	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
200	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
201	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Study Chair: Vivek Roy, MD, FACP, Mayo Clinic
• Study Chair: Philip J. Stella, MD, CCOP - Michigan Cancer Research Consortium
• Principal Investigator: Tom R. Fitch, M.D., Mayo Clinic
• Principal Investigator: Timothy J. Hobday, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00110084
• Other Study ID Numbers: CDR0000423195; U10CA025224; N0531; 855-05; N0433
• First Posted: May 4, 2005
• Last Update Posted: Jun 2, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: recurrent breast cancer; stage IV breast cancer
• Additional relevant MeSH terms: Breast Neoplasms; Gemcitabine; Paclitaxel; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 22 medical clinics in the United States between November 2005 to May 2006

Arm/Group Title	Nab-paclitaxel/Gemcitabine
Arm/Group Description	Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
Period Title: Overall Study
STARTED	50
COMPLETED	22
NOT COMPLETED	28

Baseline Characteristics

Arm/Group Title	Nab-paclitaxel/Gemcitabine
Arm/Group Description	Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
Overall Participants	50
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	56
Sex/Gender, Customized (participants) [Number]
Female	50 100%
Region of Enrollment (participants) [Number]
United States	50 100%
Dominant disease site (participants) [Number]
Soft tissue	5 10%
Osseous	4 8%
Visceral	41 82%
Estrogen receptor status (participants) [Number]
Positive	34 68%
Negative	14 28%
Unknown	2 4%
HER2 (human epidermal growth factor receptor 2) status (participants) [Number]
Positive	1 2%
Negative	49 98%
Number of metastatic sites (participants) [Number]
1	5 10%
2	15 30%
3+	30 60%
Performance Score (participants) [Number]
0 - Fully Active	23 46%
1 - Ambulatory, restricted strenuous activity	27 54%
Progesterone receptor status (participants) [Number]
Positive	28 56%
Negative	20 40%
Unknown	2 4%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients With Confirmed Responses
Description	Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
Time Frame	Two consecutive evaluations at least 6 weeks apart

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Nab-paclitaxel/Gemcitabine
Arm/Group Description	Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
Measure Participants	50
Confirmed response	25 50%
Assessable	50 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nab-paclitaxel/Gemcitabine
	Comments	Proportion of confirmed responses was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Proportion of confirmed responses (%)
	Estimated Value	50
	Confidence Interval	(2-Sided) 95%; 36 to 64
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.

2. Secondary Outcome

Title	Progression-free Survival
Description	Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.
Time Frame	Time from registration to progression or death (up to 5 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nab-paclitaxel/Gemcitabine
Arm/Group Description	Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
Measure Participants	50
Median (95% Confidence Interval) [months]	7.9

3. Secondary Outcome

Title	Overall Survival
Description	Overall survival time was defined as the number of days from registration to the date of death or last follow-up
Time Frame	Death or last follow-up (up to 5 years)

Outcome Measure Data

Analysis Population Description

Median survival time from Kaplan-meir estimate has not been attained.

Arm/Group Title	Nab-paclitaxel/Gemcitabine
Arm/Group Description	Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
Measure Participants	0

4. Secondary Outcome

Title	Adverse Event
Description	Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0
Time Frame	Every 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nab-paclitaxel/Gemcitabine
Arm/Group Description	Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
Measure Participants	50
Neutropenia	27 54%
Fatigue	14 28%
Anemia	7 14%
Dyspnea	7 14%
Thrombocytopenia	6 12%
Arthralgia	4 8%
Vomiting	4 8%
Neuropathy	3 6%
Myalgia	3 6%
Nausea	3 6%
Pain-abdominal	3 6%
Aspartate aminotransferase (AST)	3 6%

Adverse Events

Arm/Group Title	Nab-paclitaxel/Gemcitabine
Arm/Group Description	Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
All Cause Mortality
	Nab-paclitaxel/Gemcitabine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Nab-paclitaxel/Gemcitabine
	Affected / at Risk (%)	# Events
Total	11/50 (22%)
Blood and lymphatic system disorders
Anemia	3/50 (6%)	3
Febrile neutropenia	1/50 (2%)	1
Cardiac disorders
Arrythmia	1/50 (2%)	1
Gastrointestinal disorders
Ileus	1/50 (2%)	1
Nausea	1/50 (2%)	1
Pain-Abdominal	1/50 (2%)	1
Vomiting	1/50 (2%)	1
Infections and infestations
Bronchial infection	1/50 (2%)	1
Sepsis	1/50 (2%)	1
Investigations
Neutropenia	2/50 (4%)	3
Platelet count decreased	1/50 (2%)	1
Metabolism and nutrition disorders
Dehydration	1/50 (2%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/50 (2%)	1
Muscle Weakness	1/50 (2%)	1
Myalgia	1/50 (2%)	1
Nervous system disorders
Dizziness	1/50 (2%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/50 (2%)	2
Pulmonary	1/50 (2%)	1
Skin and subcutaneous tissue disorders
Erythema multiforme	1/50 (2%)	1
Vascular disorders
Hypotension	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Nab-paclitaxel/Gemcitabine
	Affected / at Risk (%)	# Events
Total	50/50 (100%)
Blood and lymphatic system disorders
Anemia	47/50 (94%)	302
Cardiac disorders
Atrial fibrillation	2/50 (4%)	2
Supraventricular tachycardia	1/50 (2%)	1
Eye disorders
Vision-Blurred	1/50 (2%)	1
Gastrointestinal disorders
Constipation	3/50 (6%)	3
Diarrhea-No Colostom	18/50 (36%)	33
Nausea	30/50 (60%)	101
Oral cavity Mucositis/stomatitis (clinical exam)	1/50 (2%)	1
Oral cavity Mucositis/stomatitis (functional/symptomatic)	18/50 (36%)	35
Pain-Abdominal	4/50 (8%)	7
Pain-Stomach	1/50 (2%)	1
Vomiting	18/50 (36%)	34
General disorders
Edema: Head/Neck	1/50 (2%)	1
Edema: Limb	8/50 (16%)	14
Edema: trunk/genital	1/50 (2%)	1
Fatigue	48/50 (96%)	269
Fever-No ANC	16/50 (32%)	26
Pain	3/50 (6%)	3
Immune system disorders
Hypersensitivity	1/50 (2%)	1
Infections and infestations
Bladder infection	3/50 (6%)	3
Bronchial infection	1/50 (2%)	1
Catheter related infection	1/50 (2%)	1
Infection	3/50 (6%)	5
Lung (pneumonia) infection	1/50 (2%)	1
Pleural infection	1/50 (2%)	1
Sepsis	1/50 (2%)	1
Sinus infection	1/50 (2%)	2
Skin (cellulites) infection	1/50 (2%)	1
Skin infection	3/50 (6%)	3
Urinary tract infection	3/50 (6%)	4
Investigations
Alanine aminotransferase increased	7/50 (14%)	14
Alkaline phosphatase	2/50 (4%)	5
Amylase	1/50 (2%)	1
Aspartate aminotransferase increased	7/50 (14%)	12
Blood bilirubin increased	1/50 (2%)	1
Leukopenia	10/50 (20%)	16
Lipase increased	1/50 (2%)	5
Lymphopenia	1/50 (2%)	1
Metabolic/Lab	1/50 (2%)	2
Neutropenia	44/50 (88%)	194
Platelet count decreased	40/50 (80%)	121
Weight gain	1/50 (2%)	1
Weight loss	1/50 (2%)	6
Metabolism and nutrition disorders
Anorexia	5/50 (10%)	9
Dehydration	1/50 (2%)	1
Hyperglycemia	3/50 (6%)	6
Hypoalbuminemia	4/50 (8%)	21
Hypocalcemia	4/50 (8%)	5
Hypokalemia	2/50 (4%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	30/50 (60%)	117
Back pain	1/50 (2%)	5
Bone pain	2/50 (4%)	2
Chest wall pain	1/50 (2%)	4
Extremity-lower weakness	1/50 (2%)	1
Muscle Weakness	3/50 (6%)	3
Myalgia	29/50 (58%)	94
Nervous system disorders
Ataxia	1/50 (2%)	1
Dizziness	1/50 (2%)	2
Dysgeusia	1/50 (2%)	3
Headache	2/50 (4%)	3
Peripheral motor neuropathy	1/50 (2%)	2
Peripheral sensory neuropathy	26/50 (52%)	145
Syncope	1/50 (2%)	1
Psychiatric disorders
Depression	1/50 (2%)	2
Renal and urinary disorders
Proteinuria	1/50 (2%)	1
Respiratory, thoracic and mediastinal disorders
Cough	3/50 (6%)	4
Dyspnea	30/50 (60%)	115
Hypoxia	1/50 (2%)	1
Pharynx Mucositis/stomatitis (functional/symptomatic)	2/50 (4%)	2
Pleural effusion	1/50 (2%)	1
Pneumonitis	1/50 (2%)	1
Skin and subcutaneous tissue disorders
Alopecia	45/50 (90%)	304
Dry skin	1/50 (2%)	1
Hand-foot skin reaction	5/50 (10%)	16
Pruritus	2/50 (4%)	3
Rash/Desquamation	4/50 (8%)	7
Skin Irritation	1/50 (2%)	1
Vascular disorders
Flushing	1/50 (2%)	3
Phlebitis	1/50 (2%)	1
Thrombosis	1/50 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.