Study of Amrubicin in Patients With Small Cell Lung Cancer Refractory or Progressive to Prior Therapy

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00375193

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

1.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the objective tumor response rate of amrubicin when administered as second-line therapy to ED-SCLC patients who have refractory or progressive disease.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: Amrubicin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Trial of Single-Agent Amrubicin in Patients With Extensive Disease Small Cell Lung Cancer That is Refractory or Progressive Within 90 Days of Completion of First Line Platinum-based Chemotherapy

Actual Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until cycle 6 or no longer beneficial.	Drug: Amrubicin Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial

Arm

Intervention/Treatment

Experimental: 1

Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until cycle 6 or no longer beneficial.

Drug: Amrubicin

Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial

Outcome Measures

Primary Outcome Measures

Objective tumor response rate according to RECIST [Until Disease Progression]

Secondary Outcome Measures

Duration of overall response [Until Disease Progression]
Time to tumor progression [Until Disease Progression]
Progression free survival [Until death or disease progression]
Overall survival [Until death]
Toxicity profile [Until 30 days after final dose]
Incidence of cardiomyopathy [Until end of study participation]
Incidence of CNS progression [Until disease progression]
Pharmacokinetic parameters [Cycle 1 only]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological or cytological diagnosis of SCLC; extensive-disease (ED) at time of study entry
Refractory to first-line platinum-based chemotherapy (i.e., has received one prior platinum-based chemotherapy regimen) defined as one of the following:
Best response to first-line chemotherapy is radiographically documented progression (refractory disease)
Best response to first-line chemotherapy is radiographically documented response or stable disease, with subsequent documented progression during continuing chemotherapy (resistant relapse)
Documented progression within 90 days of completion of first-line chemotherapy (last dose of chemotherapy), regardless of best response to treatment (resistant relapse)
At least 18 years of age
ECOG Performance Status of 0, 1, or 2
Measurable disease defined by RECIST criteria
Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology and/or cytology.
Measurable lesion: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20mm using conventional techniques or ≥10mm using spiral CT scans.
CT (including spiral CT) scans and MRI are the preferred methods of measurement; however, chest x-rays are acceptable if the lesions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.
Adequate organ function including the following:
Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1500 cells/μL, platelet count ≥100,000 cells/μL and hemoglobin ≥9g/dL.
Hepatic: bilirubin ≤ 1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 X ULN.
Renal: serum creatinine < 2.0 mg/dL or calculated creatinine clearance >60 mL/min.
Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA or echocardiography (intra-patient reassessment of LVEF should be performed via the same method throughout the study).
Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-bearing potential, use of effective contraceptive methods during the study.
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.

Exclusion Criteria:

Pregnant or nursing women
Chest radiotherapy within the previous 28 days or other radiotherapy within the previous 14 days. Recovery from the acute toxic effects of radiation required prior to study enrollment. Measurable lesions that have been previously irradiated must be enlarging to be considered target lesions. Prior radiation therapy allowed to < 25% of the bone marrow.
More than 1 prior chemotherapy regiment for SCLC
Prior anthracycline treatment
Treatment with any investigational agent within 28 days or standard chemotherapy within 21 days prior to first dose. Patients must have recovered from all acute adverse effecxts of prior therapies, excluding alopecia
Patients with secondary primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 2 years previously with surgery and/or radiotherapy and no evidence of recurrence since that time)
Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for ≥ 2 weeks and off corticosteroids for ≥ 1 week.
History of interstitial lung disease or pulmonary fibrosis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology Oncology Associates	Phoenix	Arizona	United States	85012
2	Rocky Mountain Cancer Center - Sky Ridge	Lone Tree	Colorado	United States	80124
3	Ocala Oncology Center	Ocala	Florida	United States	34474
4	Cancer Centers of Florida, PA	Ocoee	Florida	United States	34761
5	John B. Amos Cancer Center	Columbus	Georgia	United States	31904
6	Cancer Care & Hematology Specialists of Chicago	Niles	Illinois	United States	60714
7	Oncology & Hematology of Central Illinois	Peoria	Illinois	United States	61602
8	Blessing Cancer Center	Quincy	Illinois	United States	62301
9	Central Indiana Cancer Centers - Indianapolis	Indianapolis	Indiana	United States	46227
10	Norton Healthcare - Louisville Oncology	Louisville	Kentucky	United States	40202
11	Maryland Oncology Hematology, PA	Columbia	Maryland	United States	21044
12	Alliance Hematology Oncology, PA - Carroll County Cancer Center	Westminster	Maryland	United States	21157
13	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
14	Minnesota Onc/Hem, PA - Minneapolis	Minneapolis	Minnesota	United States	55404
15	University of MN/Division of Hematology, Oncology & Transplantation	Minneapolis	Minnesota	United States	55455
16	Missouri Cancer Associates	Columbia	Missouri	United States	65201
17	St. Joseph Oncology, Inc.	Saint Joseph	Missouri	United States	64507
18	Arch Medical Group - Arch Medical Services, Inc.	Saint Louis	Missouri	United States	63141
19	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89109
20	New York Oncology Hematology, PC	Albany	New York	United States	12208
21	SUNY Upstate Medical Center	Syracuse	New York	United States	13210
22	Northwestern Carolina Oncology & Hematology	Hickory	North Carolina	United States	28602
23	Raleigh Hematology Oncology Associates	Raleigh	North Carolina	United States	27607
24	Willamette Valley Cancer Center	Eugene	Oregon	United States	97401
25	Medical Oncology Associates	Kingston	Pennsylvania	United States	18704
26	University of Tennessee Medical Center, Knoxville	Knoxville	Tennessee	United States	37920
27	Sarah Cannon	Nashville	Tennessee	United States	37203
28	Texas Oncology - Amarillo	Amarillo	Texas	United States	79106
29	Mamie McFaddin Ward Cancer Center	Beaumont	Texas	United States	77702-1449
30	Texas Oncology, PA - Bedford	Bedford	Texas	United States	76022
31	Texas Cancer Center at Medical City	Dallas	Texas	United States	75230-2510
32	Texas Oncology, P.A. - Dallas	Dallas	Texas	United States	75246
33	Texas Oncology, P.A., Sammons Cancer Center	Dallas	Texas	United States	75246
34	Texas Oncology, PA - Fort Worth	Fort Worth	Texas	United States	76104
35	West Texas Cancer Center	Odessa	Texas	United States	79761
36	Tyler Cancer Center	Tyler	Texas	United States	75702
37	Texas Oncology Cancer Care and Research Center	Waco	Texas	United States	76712
38	Texas Oncology, PA - Deke Slayton Cancer Center	Webster	Texas	United States	77598
39	Texas Oncology - Wichita Falls	Wichita Falls	Texas	United States	76310
40	Virginia Oncology Associates - Norfolk, VA	Norfolk	Virginia	United States	23502
41	Oncology & Hematology Associates of Southwest Virginia, Inc.	Salem	Virginia	United States	24153
42	Puget Sound Cancer Center	Seattle	Washington	United States	98133
43	Northwest Cancer Specialists - Vancouver Cancer Center	Vancouver	Washington	United States	98684
44	Yakima Regional Cancer Care Center - North Star Lodge Cancer Center	Yakima	Washington	United States	98902
45	Free University Medical Center	Amsterdam		Netherlands	NL 1081 HV
46	Royal Marsden Hospital in Downs Road	Sutton	Surrey	United Kingdom