Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Terminated
• CT.gov ID: NCT00004859
• Collaborator: (none)
• Enrollment: 589
• Locations: 236
• Arms: 2
• Duration (Months): 122
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin; Drug: paclitaxel; Drug: thalidomide; Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES:

1. Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy with or without thalidomide.

2. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups.

3. Determine whether the inactivation of p16, Death-associated protein kinase (DAP-kinase), O6-methylguanine-DNA methyltransferase (MGMT) gene, or tissue-inhibitor of metalloproteinase 3 (TIMP-3) genes can be used to predict survival in these patients treated with this regimen.

4. Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are stratified according to disease histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and time of randomization (before addition of chemoradiotherapy vs after). Patients are randomized to one of two treatment arms.

ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression.

ARM B: Patients receive paclitaxel and carboplatin as in arm A. Patients also receive oral thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the absence of disease progression.

Beginning between days 43-50, patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy (RT) 5 days a week for 6 weeks. Arm B patients continue oral thalidomide.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 589 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)
• Study Start Date: Jan 1, 2000
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A (Paclitaxel + Carboplatin + RT) Induction chemotherapy dosing: Paclitaxel, 225 mg/m² (3 hour infusion) Day 1. Carboplatin, area under the plasma drug concentration versus time curve (AUC) =6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 Concurrent chemotherapy / radiotherapy dosing: Paclitaxel, 45 mg/m2, administered weekly during radiotherapy over one hour. Carboplatin, AUC=2, 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV	Drug: carboplatin; Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy; Other Names: CBDCA Paraplatin JM-8 NSC 241240 ; Drug: paclitaxel; Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour; Other Names: Taxol NSC 125973 ; Radiation: radiation therapy; Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV; Other Names: thoracic radiotherapy
Experimental: Arm B (Paclitaxel + Carboplatin + RT+ Thalidomide) paclitaxel, carboplatin, and radiotherapy are same as those in Arm A. thalidomide: Induction chemotherapy dosing, oral daily, starting Day 1 for 24 months or until disease progression. Concurrent chemotherapy / radiotherapy dosing, oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.	Drug: carboplatin; Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy; Other Names: CBDCA Paraplatin JM-8 NSC 241240 ; Drug: paclitaxel; Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour; Other Names: Taxol NSC 125973 ; Drug: thalidomide; Induction Chemotherapy dosing: oral daily, starting Day 1 for 24 months or until disease progression. Concurrent Chemotherapy / Radiotherapy dosing: oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.; Other Names: (d,1)-N phthalidoglutarimide Thalomid NSC #66847 IND # 48832 ; Radiation: radiation therapy; Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV; Other Names: thoracic radiotherapy

Outcome Measures

Primary Outcome Measures

1. Overall Survival Time [every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5]

   Survival time is defined as time from study entry to death from any cause

Secondary Outcome Measures

1. Time to Disease Progression [every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year]

   Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

2. Response Rate at Best Response to Treatment [every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year]

   Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma

• Squamous cell

• Adenocarcinoma

• Large cell undifferentiated

• Bronchoalveolar

• Non-small cell carcinoma not otherwise stated

• Unresectable stage IIIA

• Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability

OR

• Stage IIIB disease without significant pleural effusion

• Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative

• Metastases to contralateral, mediastinal, or supraclavicular nodes allowed

• Bidimensionally measurable or evaluable disease

• 18 and over

• ECOG performance status 0-1

• Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to registration:

• Platelet count at least 100,000/mm^3

• White Blood Cell (WBC) count at least 4,000/mm^{3 OR absolute neutrophil count at least 2,000/mm}3

• Bilirubin normal

• Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal

• Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

• Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy

• Concurrent filgrastim (G-CSF) allowed for persistent neutropenia

Exclusion Criteria:

• Positive pregnancy test,pregnant or nursing

• Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year

• Serious cardiac arrhythmias requiring medication

• Prior radiotherapy to only area of measurable or active tumor

• Less than 5 years since prior chemotherapy

• Other active malignancies

• Serious uncontrolled active infection

• Evidence of greater than grade 1 neuropathy by history or physical examination

• History of seizure disorders

• Contraindication to daily low-dose (81 mg/day) aspirin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center	Ft. Smith	Arkansas	United States	72903
2	Memorial Medical Center Cancer Services	Modesto	California	United States	95355
3	Salinas Valley Memorial Hospital	Salinas	California	United States	93901
4	Stanford Comprehensive Cancer Center at Stanford University Medical Center	Stanford	California	United States	94305
5	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
6	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
7	Memorial Hospital	Colorado Springs	Colorado	United States	80909
8	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
9	Porter Adventist Hospital	Denver	Colorado	United States	80210
10	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
11	St. Joseph Hospital	Denver	Colorado	United States	80218
12	Rose Medical Center	Denver	Colorado	United States	80220
13	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224-2522
14	Swedish Medical Center	Englewood	Colorado	United States	80110
15	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
16	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
17	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80502
18	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
19	North Suburban Medical Center	Thornton	Colorado	United States	80229
20	Praxair Cancer Center at Danbury Hospital	Danbury	Connecticut	United States	06810
21	William W. Backus Hospital	Norwich	Connecticut	United States	06360
22	Halifax Medical Center - Daytona Beach	Daytona Beach	Florida	United States	32115
23	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida	United States	32207
24	Veterans Affairs Medical Center - Augusta	Augusta	Georgia	United States	30904
25	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912
26	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
27	Medical Center of Central Georgia	Macon	Georgia	United States	31208
28	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
29	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia	United States	31603
30	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
31	Mercy Hospital and Medical Center	Chicago	Illinois	United States	60616
32	Swedish Covenant Hospital	Chicago	Illinois	United States	60625
33	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
34	Midwest Center for Hematology/Oncology	Joliet	Illinois	United States	60432
35	Trinity Medical Center - East	Moline	Illinois	United States	61265
36	Swedish-American Regional Cancer Center	Rockford	Illinois	United States	61104-2315
37	Hematology/Oncology of the North Shore at Gross Point Medical Center	Skokie	Illinois	United States	60076
38	Elkhart General Hospital	Elkhart	Indiana	United States	46515
39	Howard Community Hospital at Howard Regional Health System	Kokomo	Indiana	United States	46904
40	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
41	Reid Hospital & Health Care Services, Incorporated	Richmond	Indiana	United States	47374
42	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
43	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
44	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
45	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
46	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
47	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
48	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
49	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa	United States	52803
50	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
51	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
52	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
53	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
54	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
55	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
56	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
57	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
58	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
59	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
60	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa	United States	50266
61	Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County	Madisonville	Kentucky	United States	42431
62	DeCesaris Cancer Institute at Anne Arundel Medical Center	Annapolis	Maryland	United States	21401
63	Tufts-NEMC Cancer Center	Boston	Massachusetts	United States	02111
64	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
65	Baystate Regional Cancer Program at D'Amour Center for Cancer Care	Springfield	Massachusetts	United States	01199
66	Morton Hospital & Medical Center	Taunton	Massachusetts	United States	02780
67	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
68	St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
69	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
70	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
71	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
72	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
73	Hurley Medical Center	Flint	Michigan	United States	48503
74	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
75	Green Bay Oncology, Limited - Iron Mountain	Iron Mountain	Michigan	United States	49801
76	Foote Hospital	Jackson	Michigan	United States	49201
77	Borgess Medical Center	Kalamazooaa	Michigan	United States	49001
78	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
79	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
80	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
81	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48909
82	Mercy Memorial Hospital System	Monroe	Michigan	United States	48162
83	Seton Cancer Institute - Saginaw	Saginaw	Michigan	United States	48601
84	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	St. Joseph	Michigan	United States	49085
85	St. John Macomb Hospital	Warren	Michigan	United States	48093
86	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
87	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
88	CCOP - Duluth	Duluth	Minnesota	United States	55805
89	Miller-Dwan Medical Center	Duluth	Minnesota	United States	55805
90	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota	United States	55805
91	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
92		Fergus Falls	Minnesota	United States	56537
93	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
94	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
95	Meeker County Memorial Hospital	Lichfield	Minnesota	United States	55355
96	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
97	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
98	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
99	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota	United States	55422-2900
100	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
101	Saint Francis Cancer Center	Shakopee	Minnesota	United States	55379
102	St. Joseph's Hospital	St Paul	Minnesota	United States	55102
103	CentraCare Clinic - River Campus	St. Cloud	Minnesota	United States	56303
104	Park Nicollet Health Services	St. Louis Park	Minnesota	United States	55416
105	Regions Hospital Cancer Care Center	St. Paul	Minnesota	United States	55101
106	United Hospital	St. Paul	Minnesota	United States	55102
107	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
108	Woodwinds Health Campus	Woodbury	Minnesota	United States	55125
109	CCOP - Kansas City	Kansas City	Missouri	United States	64131
110	St. John's Regional Health Center	Springfield	Missouri	United States	65804
111	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
112	Missouri Baptist Cancer Center	St. Louis	Missouri	United States	63131
113	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
114	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
115	Deaconess Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
116	Big Sky Oncology	Great Falls	Montana	United States	59405
117	Great Falls Clinic	Great Falls	Montana	United States	59405
118	Sletten Regional Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
119		Great Falls	Montana	United States	59405
120	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
121	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
122	Immanuel Medical Center	Omaha	Nebraska	United States	68122
123	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
124	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
125	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
126	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07018-1095
127	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey	United States	08822
128	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
129	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey	United States	08053
130	Mountainside Hospital Cancer Center	Montclair	New Jersey	United States	07042
131	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
132	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
133	Warren Hospital	Phillipsburg	New Jersey	United States	08865
134	Booker Cancer Center at Riverview Medical Center	Red Bank	New Jersey	United States	07701
135	Shore Memorial Hospital - Somers Point	Somers Point	New Jersey	United States	08244
136	Overlook Hospital	Summit	New Jersey	United States	07902
137	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey	United States	08043
138	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York	United States	10461
139	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York	United States	10466
140	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
141	Lipson Cancer and Blood Center at Rochester General Hospital	Rochester	New York	United States	14621
142	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York	United States	13057
143	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
144	Wilson Medical Center	Wilson	North Carolina	United States	27893-3428
145	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
146	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota	United States	58501
147	Mid Dakota Clinic, P. C.	Bismarck	North Dakota	United States	58501
148	St. Alexius Medical Center	Bismarck	North Dakota	United States	58502
149	Akron City Hospital	Akron	Ohio	United States	44309-2090
150	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio	United States	44710-1799
151	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
152	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
153	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
154	CCOP - Columbus	Columbus	Ohio	United States	43215
155	Grant Riverside Cancer Services	Columbus	Ohio	United States	43215
156	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
157	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
158	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
159	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
160	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
161	Grady Memorial Hospital	Delaware	Ohio	United States	43015
162	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
163	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
164	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
165	Fairfield Medical Center	Lancaster	Ohio	United States	43130
166	St. Rita's Medical Center	Lima	Ohio	United States	45801
167	Lima Memorial Hospital	Lima	Ohio	United States	45804
168	MedCentral - Mansfield Hospital	Mansfield	Ohio	United States	44903
169	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
170	St. Luke's Hospital	Maumee	Ohio	United States	43537
171	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43623
172	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
173	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
174	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
175	Mercy Medical Center	Springfield	Ohio	United States	45504
176	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
177	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
178	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
179	Toledo Hospital	Toledo	Ohio	United States	43606
180	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
181	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
182	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623
183	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
184	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
185	Fulton County Health Center	Wauseon	Ohio	United States	43567
186	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
187	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
188	Geisinger Medical Center	Danville	Pennsylvania	United States	17822-0001
189	Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center	Dubois	Pennsylvania	United States	15801
190	Easton Regional Cancer Center at Easton Hospital	Easton	Pennsylvania	United States	18042
191	PinnacleHealth Regional Cancer Center at Polyclinic Hospital	Harrisburg	Pennsylvania	United States	17105
192	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
193	Lancaster General Hospital	Lancaster	Pennsylvania	United States	17604
194	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
195	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
196	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
197	Cancer Center at Phoenixville Hospital	Phoenixville	Pennsylvania	United States	19460
198	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
199	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15232
200	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania	United States	19464
201	Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052
202	Mercy Hospital Cancer Center - Scranton	Scranton	Pennsylvania	United States	18501
203	Hematology and Oncology Associates	Scranton	Pennsylvania	United States	18510
204	Grand View Hospital	Sellersville	Pennsylvania	United States	18960
205	Mount Nittany Medical Center	State College	Pennsylvania	United States	16803
206	Jennersville Regional Hospital	West Grove	Pennsylvania	United States	19390-9499
207	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
208	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
209	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania	United States	19096
210	Cancer Care Institute of Carolina at Aiken Regional Medical Centers	Aiken	South Carolina	United States	29801
211	CCOP - Greenville	Greenville	South Carolina	United States	29615
212	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
213	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
214	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57117-5039
215	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37662
216	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee	United States	37208-3599
217	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
218	University of Virginia Cancer Center at UV Health System	Charlottesville	Virginia	United States	22908
219	Danville Regional Medical Center	Danville	Virginia	United States	24541
220	Southwest Virginia Regional Cancer Center	Norton	Virginia	United States	24273
221	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia	United States	23298-0037
222	West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division	Charleston	West Virginia	United States	25304
223	Marshall University Medical Center	Huntington	West Virginia	United States	25701
224	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
225	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
226	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
227	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
228	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
229	Dean Medical Center - Madison	Madison	Wisconsin	United States	53717
230	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
231	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
232	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
233	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
234	All Saints Cancer Center at All Saints Healthcare	Racine	Wisconsin	United States	53405
235	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
236	Pretoria Academic Hospital	Pretoria		South Africa	0001

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Study Chair: Joan H. Schiller, MD, Simmons Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00004859
• Other Study ID Numbers: NCI-2012-02943; U10CA021115; E3598; CDR0000067510
• First Posted: Jan 27, 2003
• Last Update Posted: Jun 2, 2014
• Last Verified: Feb 1, 2013

• Keywords provided by National Cancer Institute (NCI): squamous cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Thalidomide; Paclitaxel; Carboplatin

Study Results

Participant Flow

Recruitment Details	The study was activated on January 27, 2000, and was terminated on October 26, 2006. 589 patients were enrolled to the study.

Arm/Group Title	Arm A (Paclitaxel + Carboplatin + Radiation )	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Arm/Group Description	Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.	Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.
Period Title: Overall Study
STARTED	295	294
Eligible	275	271
Treated	289	289
Treated and Having Toxicity Data	289	288
COMPLETED	177	12
NOT COMPLETED	118	282

Baseline Characteristics

Arm/Group Title	Arm A (Paclitaxel + Carboplatin + Radiation )	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)	Total
Arm/Group Description	Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.	Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.	Total of all reporting groups
Overall Participants	275	271	546
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (9.0)	62.2 (10.5)	62.6 (9.8)
Sex: Female, Male (Count of Participants)
Female	104 37.8%	108 39.9%	212 38.8%
Male	171 62.2%	163 60.1%	334 61.2%

Outcome Measures

1. Secondary Outcome

Title	Time to Disease Progression
Description	Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Time Frame	every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Paclitaxel + Carboplatin + Radiation )	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Arm/Group Description	active comparator	experimental arm
Measure Participants	275	271
Median (95% Confidence Interval) [Months]	7.4	7.8

2. Secondary Outcome

Title	Response Rate at Best Response to Treatment
Description	Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.
Time Frame	every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A (Paclitaxel + Carboplatin + Radiation )	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Arm/Group Description	Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.	Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.
Measure Participants	275	271
Number (95% Confidence Interval) [Proportion of participants]	0.35 0.1%	0.38 0.1%

3. Primary Outcome

Title	Overall Survival Time
Description	Survival time is defined as time from study entry to death from any cause
Time Frame	every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5

Outcome Measure Data

Analysis Population Description

intent to treat analysis in the 546 eligible patients

Arm/Group Title	Arm A (Paclitaxel + Carboplatin + Radiation )	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Arm/Group Description	active comparator	experimental arm
Measure Participants	275	271
Median (95% Confidence Interval) [Months]	15.3	16.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A (Paclitaxel + Carboplatin + Radiation ), Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	Log Rank
	Comments

Adverse Events

Time Frame	Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Arm/Group Title	Arm A (Paclitaxel + Carboplatin + Radiation )		Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Arm/Group Description	Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.		Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.
All Cause Mortality
	Arm A (Paclitaxel + Carboplatin + Radiation )		Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A (Paclitaxel + Carboplatin + Radiation )		Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	222/289 (76.8%)		249/288 (86.5%)
Blood and lymphatic system disorders
Anemia	8/289 (2.8%)		4/288 (1.4%)
Transfusion: platelets	1/289 (0.3%)		0/288 (0%)
Transfusion:pRBCs	15/289 (5.2%)		6/288 (2.1%)
Febrile neutropenia	8/289 (2.8%)		7/288 (2.4%)
Cardiac disorders
Sinus bradycardia	0/289 (0%)		2/288 (0.7%)
Sinus tachycardia	1/289 (0.3%)		1/288 (0.3%)
Supraventricular arrhythmias	2/289 (0.7%)		6/288 (2.1%)
Ventricular function	2/289 (0.7%)		1/288 (0.3%)
Pericardial effusion/pericarditis	1/289 (0.3%)		1/288 (0.3%)
Cardiac-other	1/289 (0.3%)		0/288 (0%)
Chest pain	2/289 (0.7%)		2/288 (0.7%)
Ear and labyrinth disorders
Inner ear/hearing imparied	1/289 (0.3%)		0/288 (0%)
Hearing-other	1/289 (0.3%)		0/288 (0%)
Vertigo	1/289 (0.3%)		2/288 (0.7%)
Earache	0/289 (0%)		1/288 (0.3%)
Eye disorders
Ocular-other	0/289 (0%)		1/288 (0.3%)
Gastrointestinal disorders
Constipation	4/289 (1.4%)		26/288 (9%)
Dyspepsia	3/289 (1%)		0/288 (0%)
Dysphagia	1/289 (0.3%)		2/288 (0.7%)
Fistula-intestinal	1/289 (0.3%)		0/288 (0%)
Ileus	0/289 (0%)		2/288 (0.7%)
Nausea	17/289 (5.9%)		14/288 (4.9%)
Stomatitis	8/289 (2.8%)		7/288 (2.4%)
Taste disturbance	0/289 (0%)		1/288 (0.3%)
Vomiting	14/289 (4.8%)		7/288 (2.4%)
Diarrhea w/o prior colostomy	5/289 (1.7%)		8/288 (2.8%)
GI-other	0/289 (0%)		1/288 (0.3%)
Melena/GI bleeding	0/289 (0%)		1/288 (0.3%)
Abonominal pain	0/289 (0%)		1/288 (0.3%)
General disorders
Edema	1/289 (0.3%)		8/288 (2.8%)
Fatigue	16/289 (5.5%)		42/288 (14.6%)
Fever	1/289 (0.3%)		1/288 (0.3%)
Injection site reaction	0/289 (0%)		1/288 (0.3%)
Pain-other	1/289 (0.3%)		1/288 (0.3%)
Immune system disorders
Allergic reaction	16/289 (5.5%)		13/288 (4.5%)
Infections and infestations
Infection w/ grade 3 or 4 neutropenia	9/289 (3.1%)		15/288 (5.2%)
Infection w/ unknown ANC	1/289 (0.3%)		3/288 (1%)
Infection w/o neutropenia	5/289 (1.7%)		5/288 (1.7%)
Injury, poisoning and procedural complications
Radiation dermatitis	3/289 (1%)		2/288 (0.7%)
Wound -infectious	0/289 (0%)		1/288 (0.3%)
Wound -non infectious	1/289 (0.3%)		0/288 (0%)
Dysphagia-esophageal radiation	4/289 (1.4%)		3/288 (1%)
Mucositis due to radiation	1/289 (0.3%)		0/288 (0%)
Pain due to radiation	2/289 (0.7%)		2/288 (0.7%)
Investigations
Leukopenia	69/289 (23.9%)		81/288 (28.1%)
Lymphopenia	2/289 (0.7%)		2/288 (0.7%)
Neutropenia	146/289 (50.5%)		161/288 (55.9%)
Thrombocytopenia	10/289 (3.5%)		6/288 (2.1%)
Weight gain	0/289 (0%)		1/288 (0.3%)
Weight loss	2/289 (0.7%)		5/288 (1.7%)
Elevated Partial Thromboplastin Time (PTT)	1/289 (0.3%)		0/288 (0%)
Elevated Prothrombin Time (PT)	0/289 (0%)		1/288 (0.3%)
Bilirubin increased	0/289 (0%)		1/288 (0.3%)
AST increased	1/289 (0.3%)		0/288 (0%)
ALT increased	1/289 (0.3%)		0/288 (0%)
Creatinine increased	0/289 (0%)		1/288 (0.3%)
Metabolism and nutrition disorders
Anorexia	10/289 (3.5%)		12/288 (4.2%)
Dehydration	10/289 (3.5%)		6/288 (2.1%)
Hypercalcemia	0/289 (0%)		2/288 (0.7%)
Hyperglycemia	8/289 (2.8%)		4/288 (1.4%)
Hyperkalemia	1/289 (0.3%)		1/288 (0.3%)
Hypokalemia	3/289 (1%)		11/288 (3.8%)
Hyponatremia	14/289 (4.8%)		15/288 (5.2%)
Musculoskeletal and connective tissue disorders
Muscle weakness	2/289 (0.7%)		3/288 (1%)
Myositis	0/289 (0%)		1/288 (0.3%)
Joint,muscle, bone-other	0/289 (0%)		1/288 (0.3%)
Arthralgia	8/289 (2.8%)		14/288 (4.9%)
Bone pain	0/289 (0%)		3/288 (1%)
Myalgia	7/289 (2.4%)		14/288 (4.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain	0/289 (0%)		1/288 (0.3%)
Nervous system disorders
Vasovagal episode	1/289 (0.3%)		0/288 (0%)
Cognitive disturbance	0/289 (0%)		1/288 (0.3%)
Depressed level of consciousness	1/289 (0.3%)		15/288 (5.2%)
Memory loss	0/289 (0%)		2/288 (0.7%)
Neuropathy-motor	5/289 (1.7%)		9/288 (3.1%)
Neuropathy-sensory	16/289 (5.5%)		33/288 (11.5%)
Seizure	0/289 (0%)		1/288 (0.3%)
Syncope	4/289 (1.4%)		7/288 (2.4%)
Tremor	0/289 (0%)		5/288 (1.7%)
Neuropathic pain	2/289 (0.7%)		0/288 (0%)
Psychiatric disorders
Confusion	0/289 (0%)		2/288 (0.7%)
Dizziness/lightheadedness	1/289 (0.3%)		14/288 (4.9%)
Hallucinations	0/289 (0%)		2/288 (0.7%)
Insomnia	1/289 (0.3%)		0/288 (0%)
Depression	1/289 (0.3%)		3/288 (1%)
Renal and urinary disorders
Renal failure	1/289 (0.3%)		0/288 (0%)
Reproductive system and breast disorders
Erectile impotence	1/289 (0.3%)		0/288 (0%)
Irregular menses	0/289 (0%)		1/288 (0.3%)
Respiratory, thoracic and mediastinal disorders
Apnea	1/289 (0.3%)		1/288 (0.3%)
Cough	2/289 (0.7%)		4/288 (1.4%)
Dyspnea	19/289 (6.6%)		39/288 (13.5%)
Hiccoughs	1/289 (0.3%)		0/288 (0%)
Hypoxia	2/289 (0.7%)		9/288 (3.1%)
Pleural effusion	2/289 (0.7%)		3/288 (1%)
Pneumonitis/pulmonary infiltrates	8/289 (2.8%)		12/288 (4.2%)
Pulmonary fibrosis	3/289 (1%)		0/288 (0%)
Voice changes/dysarthria	1/289 (0.3%)		1/288 (0.3%)
Pulmonary - other	1/289 (0.3%)		0/288 (0%)
Skin and subcutaneous tissue disorders
Pruritus	1/289 (0.3%)		4/288 (1.4%)
Rash/desquamation	4/289 (1.4%)		20/288 (6.9%)
Urticaria	1/289 (0.3%)		1/288 (0.3%)
Vascular disorders
Hypertension	1/289 (0.3%)		1/288 (0.3%)
Hypotension	3/289 (1%)		8/288 (2.8%)
Peripheral arterial ischemia	0/289 (0%)		1/288 (0.3%)
Thrombosis/Embolism	6/289 (2.1%)		30/288 (10.4%)
Visceral arterial ischemia	0/289 (0%)		1/288 (0.3%)
Cerebrovascular Ischemia	0/289 (0%)		2/288 (0.7%)
Other (Not Including Serious) Adverse Events
	Arm A (Paclitaxel + Carboplatin + Radiation )		Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	283/289 (97.9%)		284/288 (98.6%)
Blood and lymphatic system disorders
Anemia	238/289 (82.4%)		238/288 (82.6%)
Gastrointestinal disorders
Constipation	85/289 (29.4%)		179/288 (62.2%)
Dyspepsia	22/289 (7.6%)		25/288 (8.7%)
Dysphagia	25/289 (8.7%)		30/288 (10.4%)
Nausea	140/289 (48.4%)		130/288 (45.1%)
Stomatitis	58/289 (20.1%)		68/288 (23.6%)
Taste disturbance	47/289 (16.3%)		54/288 (18.8%)
Vomiting	68/289 (23.5%)		50/288 (17.4%)
Diarrhea w/o prior colostomy	62/289 (21.5%)		40/288 (13.9%)
General disorders
Edema	24/289 (8.3%)		83/288 (28.8%)
Fatigue	208/289 (72%)		223/288 (77.4%)
Fever	20/289 (6.9%)		15/288 (5.2%)
Pain-other	17/289 (5.9%)		14/288 (4.9%)
Infections and infestations
Infection w/o neutropenia	27/289 (9.3%)		28/288 (9.7%)
Injury, poisoning and procedural complications
Radiation dermatitis	58/289 (20.1%)		55/288 (19.1%)
Investigations
Leukopenia	223/289 (77.2%)		229/288 (79.5%)
Neutropenia	187/289 (64.7%)		220/288 (76.4%)
Thrombocytopenia	109/289 (37.7%)		108/288 (37.5%)
Weight gain	4/289 (1.4%)		17/288 (5.9%)
Weight loss	79/289 (27.3%)		64/288 (22.2%)
Alkaline phosphatase increased	62/289 (21.5%)		56/288 (19.4%)
AST increased	34/289 (11.8%)		19/288 (6.6%)
Creatinine increased	27/289 (9.3%)		32/288 (11.1%)
Metabolism and nutrition disorders
Anorexia	110/289 (38.1%)		97/288 (33.7%)
Dehydration	15/289 (5.2%)		21/288 (7.3%)
Hyperkalemia	20/289 (6.9%)		29/288 (10.1%)
Hypokalemia	34/289 (11.8%)		45/288 (15.6%)
Hyponatremia	91/289 (31.5%)		94/288 (32.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	74/289 (25.6%)		93/288 (32.3%)
Myalgia	110/289 (38.1%)		117/288 (40.6%)
Nervous system disorders
Depressed level of consciousness	4/289 (1.4%)		73/288 (25.3%)
Dizziness/lightheadedness	20/289 (6.9%)		80/288 (27.8%)
Neuropathy-motor	34/289 (11.8%)		60/288 (20.8%)
Neuropathy-sensory	161/289 (55.7%)		206/288 (71.5%)
Tremor	3/289 (1%)		31/288 (10.8%)
Headache	28/289 (9.7%)		35/288 (12.2%)
Psychiatric disorders
Insomnia	18/289 (6.2%)		12/288 (4.2%)
Anxiety/agitation	15/289 (5.2%)		16/288 (5.6%)
Depression	8/289 (2.8%)		18/288 (6.3%)
Respiratory, thoracic and mediastinal disorders
Cough	51/289 (17.6%)		53/288 (18.4%)
Dyspnea	65/289 (22.5%)		99/288 (34.4%)
Pneumonitis/pulmonary infiltrates	21/289 (7.3%)		25/288 (8.7%)
Skin and subcutaneous tissue disorders
Alopecia	179/289 (61.9%)		176/288 (61.1%)
Dry skin	7/289 (2.4%)		25/288 (8.7%)
Pruritus	21/289 (7.3%)		18/288 (6.3%)
Rash/desquamation	49/289 (17%)		89/288 (30.9%)
Vascular disorders
Hypotension	18/289 (6.2%)		31/288 (10.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.