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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate according to RECIST

Outcome Time Frame:

Until Disease Progression

Safety Issue:

No

Principal Investigator

Richard S Ungerleider, MD

Investigator Role:

Study Director

Investigator Affiliation:

Theradex

Authority:

United States: Food and Drug Administration

Study ID:

CNF3140-SCLC-002

NCT ID:

NCT00375193

Start Date:

November 2006

Completion Date:

March 2009

Related Keywords:

  • Small Cell Lung Cancer
  • small cell lung cancer
  • amrubicin
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
Missouri Cancer AssociatesColumbia, Missouri  65201
John B. Amos Cancer CenterColumbus, Georgia  31904
Tyler Cancer CenterTyler, Texas  75702
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Medical Oncology AssociatesKingston, Pennsylvania  18704
Texas Cancer Center at Medical CityDallas, Texas  75230
West Texas Cancer CenterOdessa, Texas  79761
Hematology Oncology AssociatesPhoenix, Arizona  85012
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
Northwestern Carolina Oncology & HematologyHickory, North Carolina  28601
New York Oncology Hematology, PCAlbany, New York  12208
Oncology & Hematology Associates of Southwest Virginia, Inc.Salem, Virginia  24153
Puget Sound Cancer CenterEdmonds, Washington  98026
Maryland Oncology Hematology, PAColumbia, Maryland  21044
Texas Oncology, PA - BedfordBedford, Texas  76022
Texas Oncology Cancer Care and Research CenterWaco, Texas  76712
Cancer Centers of Florida, PAOrlando, Florida  32822
Northwest Cancer Specialists - Vancouver Cancer CenterVancouver, Washington  98684
Rocky Mountain Cancer Center - Sky RidgeLone Tree, Colorado  80124
Cancer Care & Hematology Specialists of ChicagoNiles, Illinois  60714
Oncology & Hematology of Central IllinoisPeoria, Illinois  61602
Blessing Cancer CenterQuincy, Illinois  62301
Norton Healthcare - Louisville OncologyLouisville, Kentucky  40202
Alliance Hematology Oncology, PA - Carroll County Cancer CenterWestminster, Maryland  21157
Texas Oncology, PA - Deke Slayton Cancer CenterWebster, Texas  77598
Central Indiana Cancer Centers - IndianapolisIndianapolis, Indiana  46227
University of MN/Division of Hematology, Oncology & TransplantationMinneapolis, Minnesota  55455
Minnesota Onc/Hem, PA - MinneapolisMinneapolis, Minnesota  55404
Arch Medical Group - Arch Medical Services, Inc.St. Louis, Missouri  63141
SUNY Upstate Medical CenterSyracuse, New York  13210
University of Tennessee Medical Center, KnoxvilleKnoxville, Tennessee  37920
Sarah CannonNashville, Tennessee  37203
Texas Oncology - AmarilloAmarillo, Texas  79106
Texas Oncology, P.A., Sammons Cancer CenterDallas, Texas  75246
Texas Oncology, P.A. - DallasDallas, Texas  75246
Texas Oncology, PA - Fort WorthFort Worth, Texas  76104
Texas Oncology - Wichita FallsWichita Falls, Texas  76310
Virginia Oncology Associates - Norfolk, VANorfolk, Virginia  23502
Yakima Regional Cancer Care Center - North Star Lodge Cancer CenterYakima, Washington  98902