Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00005972

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.5

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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride	Phase 2

Detailed Description

OBJECTIVES: I. Determine the overall, complete, and partial response rates of patients with recurrent or refractory small cell lung cancer when treated with gemcitabine plus irinotecan.

Determine the overall and failure free survival of these patients when treated with this regimen. III. Determine the duration of response of these patients after this treatment. IV. Evaluate the toxicity associated with the administration of this treatment in this patient population.

OUTLINE: Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study over 12-18 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for Small Cell Lung Cancer

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gemcitabine + irinotecan Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years.	Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride

Arm

Intervention/Treatment

Experimental: gemcitabine + irinotecan

Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years.

Drug: gemcitabine hydrochloride

Drug: irinotecan hydrochloride

Outcome Measures

Primary Outcome Measures

overall response rate [Up to 18 weeks]

Secondary Outcome Measures

overall survival [Up to 18 weeks]
failure-free survival [Up to 18 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory small cell lung cancer Measurable disease At least 20 mm with conventional techniques OR At least 10 mm with spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Known CNS metastases allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No prior or concurrent malignancy in past 5 years except curatively treated carcinoma in situ of the cervix, breast, or basal cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy or chemoradiotherapy regimen No prior gemcitabine or irinotecan Endocrine therapy: Not specified Radiotherapy: No more than 1 prior chemoradiotherapy regimen At least 2 weeks since prior cranial radiotherapy for CNS metastases No concurrent cranial 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
2	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
3	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
4	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
5	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
6	Lombardi Cancer Center	Washington	District of Columbia	United States	20007
7	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
8	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
9	University of Illinois at Chicago Health Sciences Center	Chicago	Illinois	United States	60612
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	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
13	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa	United States	52242-1009
14	Veterans Affairs Medical Center - Togus	Togus	Maine	United States	04330
15	Marlene & 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	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	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-3330
24	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
25	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
26	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
27	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
28	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
29	North Shore University Hospital	Manhasset	New York	United States	11030
30	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
31	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
32	Mount Sinai Medical Center, NY	New York	New York	United States	10029
33	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
34	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
35	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
36	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
37	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
38	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
39	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
40	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
41	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
42	Rhode Island Hospital	Providence	Rhode Island	United States	02903
43	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
44	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee	United States	38103
45	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee	United States	38104
46	CCOP - Southwestern Vermont Regional Cancer Center	Bennington	Vermont	United States	05201
47	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
48	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
49	Veterans Affairs Medical Center - Richmond	Richmond	Virginia	United States	23249
50	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037