Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

• Sponsor: Eastern Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00010257
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 46
• Locations: 67
• Arm: 1
• Duration (Months): 138
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.

Condition or Disease	Intervention/Treatment	Phase
Thymoma; Thymic Carcinoma	Drug: carboplatin; Drug: paclitaxel	Phase 2

Detailed Description

OBJECTIVES:

• Determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel.

• Determine the duration of response in these patients treated with this regimen.

• Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel by intravenous (IV) infusion over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression. Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further treatment may be given at the discretion of the treating physician.

Patients were followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 35-68 patients were to be accrued for this study within 3.8-4.6 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma
• Study Start Date: Feb 1, 2001
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paclitaxel plus Carboplatin Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle	Drug: carboplatin; Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles; Other Names: CBDCA Paraplatin JM-8 NSC # 241240 ; Drug: paclitaxel; 225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles; Other Names: Taxol NSC #125973

Outcome Measures

Primary Outcome Measures

1. Best Overall Response by RECIST Criteria (Version 1.0) [Assessed every 2 cycles (6 weeks)]

   Number of eligible, treated participants in each response category by RECIST criteria

Secondary Outcome Measures

1. Duration of Response [assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter]

   Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery

• Extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy)

• Advanced limited disease allowed if ineligible for primary radiotherapy or surgery

• Measurable disease

• Age 18 and over

• ECOG Performance Status 0-1

• Granulocyte count at least 1,500 cells/mm^3

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

• Bilirubin no greater than 1.5 mg/dL

• Creatinine no greater than 2.0 mg/dL

• Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed

Exclusion Criteria:

• Acute concurrent complications such as infection or post-surgical complications

• Other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence

• Pregnant or nursing. A negative pregnancy test was required, and fertile patients must use effective contraception

• Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
2	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
3	Swedish-American Regional Cancer Center	Rockford	Illinois	United States	61104-2315
4	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
5	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
6	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
7	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
8	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
9	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
10	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
11	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
12	Dickinson County Healthcare System	Iron Mountain	Michigan	United States	49801
13	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
14	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
15	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
16	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
17	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
18	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
19	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
20	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
21	Meeker County Memorial Hospital	Lichfield	Minnesota	United States	55355
22	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
23	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota	United States	55109
24	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
25	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
26	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota	United States	55422-2900
27	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
28	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota	United States	55379
29	HealthEast Cancer Care at St. Joseph's Hospital	St Paul	Minnesota	United States	55102
30	Park Nicollet Cancer Center	St. Louis Park	Minnesota	United States	55416
31	Regions Hospital Cancer Care Center	St. Paul	Minnesota	United States	55101
32	United Hospital	St. Paul	Minnesota	United States	55102
33	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
34	HealthEast Cancer Care at Woodwinds Health Campus	Woodbury	Minnesota	United States	55125
35	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota	United States	55125
36	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey	United States	08822
37	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
38	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
39	Aultman Cancer Center at Aultman Hospital	Canton	Ohio	United States	44710-1799
40	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
41	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
42	St. Rita's Medical Center	Lima	Ohio	United States	45801
43	Mercy Fitzgerald Hospital	Darby	Pennsylvania	United States	19023
44	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
45	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
46	Riddle Memorial Hospital Cancer Center	Media	Pennsylvania	United States	19063
47	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
48	Albert Einstein Cancer Center	Philadelphia	Pennsylvania	United States	19141
49	Hematology and Oncology Associates of Northeastern Pennsylvania	Scranton	Pennsylvania	United States	18510
50	Mount Nittany Medical Center	State College	Pennsylvania	United States	16803
51	Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center	Upland	Pennsylvania	United States	19013
52	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
53	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
54	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
55	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
56	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
57	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
58	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
59	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
60	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
61	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
62	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
63	Froedtert Hospital and Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
64	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
65	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
66	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
67	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235

Sponsors and Collaborators

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

Investigators

• Study Chair: Patrick J. Loehrer, MD, Indiana University Melvin and Bren Simon Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Loehrer PJ, Wang W, Aisner S, et al.: Long-term follow-up of patients with locally advanced or metastatic thymic malignancies: the Eastern Cooperative Oncology Group (ECOG) experience. [Abstract] J Clin Oncol 22 (Suppl 14): A-7050, 629s, 2004.

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT00010257
• Other Study ID Numbers: CDR0000068461; U10CA021115; E1C99
• First Posted: Jan 27, 2003
• Last Update Posted: Oct 9, 2015
• Last Verified: Jun 1, 2013

• Keywords provided by Eastern Cooperative Oncology Group: thymoma; thymic carcinoma
• Additional relevant MeSH terms: Carcinoma; Thymoma; Thymus Neoplasms; Paclitaxel; Carboplatin

Study Results

Participant Flow

Recruitment Details	The study was activated on February 21, 2001. The thymoma stratum closed to accrual on March 27, 2007. The thymic carcinoma stratum closed to accrual on January 18, 2008.

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients with diagnosis of thymoma	Patients with diagnosis of thymic carcinoma
Period Title: Overall Study
STARTED	25	21
COMPLETED	24	21
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Thymoma	Thymic Carcinoma	Total
Arm/Group Description	Patients with diagnosis of thymoma	Patients with diagnosis of thymic carcinoma	Total of all reporting groups
Overall Participants	25	21	46
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	50.8	49.2	50.7
Sex: Female, Male (Count of Participants)
Female	11 44%	6 28.6%	17 37%
Male	14 56%	15 71.4%	29 63%
Region of Enrollment (participants) [Number]
United States	25 100%	21 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Best Overall Response by RECIST Criteria (Version 1.0)
Description	Number of eligible, treated participants in each response category by RECIST criteria
Time Frame	Assessed every 2 cycles (6 weeks)

Outcome Measure Data

Analysis Population Description

Analysis population included all eligible participants who received at least 1 dose of the protocol treatment

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients with diagnosis of thymoma	Patients with diagnosis of thymic carcinoma
Measure Participants	23	20
Complete Response	3 12%	0 0%
Partial Response	5 20%	6 28.6%
Stable Disease	13 52%	8 38.1%
Progression	0 0%	4 19%
Unevaluable	2 8%	2 9.5%

2. Secondary Outcome

Title	Duration of Response
Description	Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria
Time Frame	assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter

Outcome Measure Data

Analysis Population Description

Number of participants achieving a complete or partial response by RECIST criteria

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients with diagnosis of thymoma	Patients with diagnosis of thymic carcinoma
Measure Participants	8	6
Median (95% Confidence Interval) [Months]	16.9	5.0

Adverse Events

Time Frame	Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Arm/Group Title	Thymoma		Thymic Carcinoma
Arm/Group Description	Patients with diagnosis of thymoma		Patients with diagnosis of thymic carcinoma
All Cause Mortality
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/24 (54.2%)		14/21 (66.7%)
Blood and lymphatic system disorders
Anemia	1/24 (4.2%)		2/21 (9.5%)
Leukopenia	3/24 (12.5%)		5/21 (23.8%)
Neutropenia	8/24 (33.3%)		6/21 (28.6%)
Thrombocytopenia	1/24 (4.2%)		2/21 (9.5%)
Cardiac disorders
Cardiac, Other	1/24 (4.2%)		0/21 (0%)
Gastrointestinal disorders
Nausea	1/24 (4.2%)		0/21 (0%)
Vomiting	1/24 (4.2%)		1/21 (4.8%)
Stomatitis	0/24 (0%)		1/21 (4.8%)
General disorders
Fatigue	2/24 (8.3%)		6/21 (28.6%)
Immune system disorders
Allergic Reaction	0/24 (0%)		1/21 (4.8%)
Infections and infestations
Febrile Neutropenia	0/24 (0%)		2/21 (9.5%)
Infection with grade 3-4 neutropenia	1/24 (4.2%)		1/21 (4.8%)
Investigations
Blood Bilirubin Increased	0/24 (0%)		2/21 (9.5%)
Metabolism and nutrition disorders
Anorexia	0/24 (0%)		2/21 (9.5%)
Hyperglycemia	1/24 (4.2%)		0/21 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/24 (4.2%)		0/21 (0%)
Myalgia	2/24 (8.3%)		0/21 (0%)
Nervous system disorders
Neuropathy - Sensory	4/24 (16.7%)		2/21 (9.5%)
Seizure	0/24 (0%)		1/21 (4.8%)
Skin and subcutaneous tissue disorders
Rash/desquamation	1/24 (4.2%)		0/21 (0%)
Pruritus	0/24 (0%)		1/21 (4.8%)
Other (Not Including Serious) Adverse Events
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/24 (100%)		21/21 (100%)
Blood and lymphatic system disorders
Anemia	17/24 (70.8%)		19/21 (90.5%)
Leukopenia	13/24 (54.2%)		12/21 (57.1%)
Neutropenia	15/24 (62.5%)		10/21 (47.6%)
Thrombocytopenia	5/24 (20.8%)		9/21 (42.9%)
Cardiac disorders
Chest Pain	0/24 (0%)		2/21 (9.5%)
Gastrointestinal disorders
Constipation	3/24 (12.5%)		3/21 (14.3%)
Nausea	13/24 (54.2%)		17/21 (81%)
Stomatitis	3/24 (12.5%)		7/21 (33.3%)
Taste Disturbance	3/24 (12.5%)		2/21 (9.5%)
Vomiting	9/24 (37.5%)		12/21 (57.1%)
Diarrhea w/o Prior Colostomy	5/24 (20.8%)		11/21 (52.4%)
Abdominal Pain	1/24 (4.2%)		3/21 (14.3%)
General disorders
Edema	2/24 (8.3%)		2/21 (9.5%)
Fatigue	19/24 (79.2%)		16/21 (76.2%)
Fever	2/24 (8.3%)		3/21 (14.3%)
Rigors/Chills	0/24 (0%)		2/21 (9.5%)
Immune system disorders
Allergic Reaction	0/24 (0%)		1/21 (4.8%)
Investigations
Alkaline Phosphatase Increased	1/24 (4.2%)		7/21 (33.3%)
Bilirubin Increased	0/24 (0%)		2/21 (9.5%)
AST Increased	5/24 (20.8%)		6/21 (28.6%)
ALT Increased	4/24 (16.7%)		5/21 (23.8%)
Creatinine Increased	2/24 (8.3%)		3/21 (14.3%)
Metabolism and nutrition disorders
Weight Gain	1/24 (4.2%)		2/21 (9.5%)
Anorexia	8/24 (33.3%)		9/21 (42.9%)
Dehydration	0/24 (0%)		2/21 (9.5%)
Musculoskeletal and connective tissue disorders
Muscle Weakness	0/24 (0%)		2/21 (9.5%)
Arthralgia	15/24 (62.5%)		8/21 (38.1%)
Myalgia	14/24 (58.3%)		10/21 (47.6%)
Nervous system disorders
Ataxia	2/24 (8.3%)		1/21 (4.8%)
Dizziness/Lightheadedness	3/24 (12.5%)		2/21 (9.5%)
Memory Loss	0/24 (0%)		2/21 (9.5%)
Neuropathy - Motor	3/24 (12.5%)		6/21 (28.6%)
Neuropathy - Sensory	23/24 (95.8%)		16/21 (76.2%)
Headache	3/24 (12.5%)		3/21 (14.3%)
Psychiatric disorders
Insomnia	4/24 (16.7%)		3/21 (14.3%)
Anxiety/Agitation	0/24 (0%)		3/21 (14.3%)
Renal and urinary disorders
Urinary Frequency/Urgency	0/24 (0%)		2/21 (9.5%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	0/24 (0%)		3/21 (14.3%)
Cough	2/24 (8.3%)		3/21 (14.3%)
Dyspnea	6/24 (25%)		6/21 (28.6%)
Skin and subcutaneous tissue disorders
Sweating	1/24 (4.2%)		2/21 (9.5%)
Alopecia	22/24 (91.7%)		17/21 (81%)
Nail Changes	2/24 (8.3%)		0/21 (0%)
Pigmentation	2/24 (8.3%)		0/21 (0%)
Pruritus	3/24 (12.5%)		3/21 (14.3%)
Rash/Desquamation	6/24 (25%)		4/21 (19%)
Vascular disorders
Hypotension	2/24 (8.3%)		0/21 (0%)

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.