Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00033696

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: paclitaxel Drug: topotecan hydrochloride Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy.
Determine the toxicity of this regimen in these patients.
Determine the overall and failure-free survival of patients treated with this regimen.
Determine the overall (partial and complete) response rate in patients treated with this induction chemotherapy regimen.

OUTLINE: This is a multicenter study.

Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover.
Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks.

Patients with rapid disease progression discontinue study therapy.

Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: chemotherapy + radiation therapy Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.	Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: paclitaxel Drug: topotecan hydrochloride Radiation: radiation therapy

Arm

Intervention/Treatment

Experimental: chemotherapy + radiation therapy

Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Biological: filgrastim

Drug: carboplatin

Drug: etoposide

Drug: paclitaxel

Drug: topotecan hydrochloride

Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

overall response rate [up to 5 years]

Secondary Outcome Measures

failure-free survival [up to 5 years]
overall survival [up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed small cell lung cancer
Limited stage defined as disease restricted to one hemithorax with regional lymph node metastases including hilar, ipsilateral, and contralateral mediastinal lymph nodes
Measurable disease
At least 20 mm by conventional techniques OR
At least 10 mm by spiral CT scan
Lesions not considered measurable include the following:
Bone lesions
Leptomeningeal disease
Ascites
Pleural/pericardial effusion
Abdominal masses not confirmed and followed by imaging techniques
Cystic lesions
Tumor lesions in a previously irradiated area
No clinically suspected or confirmed supraclavicular lymph node metastases
No pleural effusions visible on plain chest radiographs, regardless of cytology

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Granulocyte count at least 1,500/mm3
Platelet count at least 100,00/mm3

Hepatic:

Bilirubin less than 1.5 mg/dL
SGOT less than 2 times upper limit of normal (ULN)

Renal:

Creatinine no greater than ULN
Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No other currently active malignancy except non-melanoma skin cancer
Patients must have completed therapy for any other malignancy and be considered to be at less than 30% risk of relapse

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent filgrastim (G-CSF) during consolidation therapy

Chemotherapy:

No prior chemotherapy for small cell lung cancer
No other concurrent chemotherapy

Endocrine therapy:

No concurrent hormonal therapy except:
Steroids for adrenal failure
Hormones for non-disease-related conditions (e.g., insulin for diabetes)
Intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial irradiation

Radiotherapy:

See Disease Characteristics
No prior chest radiotherapy

Surgery:

Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center - Birmingham	Birmingham	Alabama	United States	35233-1996
2	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
3	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
4	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
5	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
6	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
7	Lombardi Cancer Center	Washington	District of Columbia	United States	20007
8	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
9	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
10	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
11	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
12	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
13	Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242-1009
14	Veterans Affairs Medical Center - Togus	Togus	Maine	United States	04330
15	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
16	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
17	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts	United States	01655
18	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
19	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
20	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
21	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
22	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
23	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
24	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
25	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
26	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
27	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
28	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
29	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
30	North Shore University Hospital	Manhasset	New York	United States	11030
31	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
32	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
33	Mount Sinai Medical Center, NY	New York	New York	United States	10029
34	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
35	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
36	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
37	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
38	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
39	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
40	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
41	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
42	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
43	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
44	Rhode Island Hospital	Providence	Rhode Island	United States	02903
45	University of Tennessee Cancer Institute	Memphis	Tennessee	United States	38103
46	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee	United States	38104
47	Green Mountain Oncology Group	Bennington	Vermont	United States	05201
48	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
49	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
50	Veterans Affairs Medical Center - Richmond	Richmond	Virginia	United States	23249
51	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037