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

NCT00375193 | Completed Phase 2

• 1 other identifier: CNF3140-SCLC-002
• Study Type: interventional
• Target: 75
• Locations: 3 countries
• Sites: 46

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; amrubicin

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate according to RECIST

  Until Disease Progression

Secondary Outcomes (8)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Amrubicin

Interventions

Amrubicin DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (46)

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Rocky Mountain Cancer Center - Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Cancer Centers of Florida, PA

Ocoee, Florida, 34761, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Cancer Care & Hematology Specialists of Chicago

Niles, Illinois, 60714, United States

Location

Oncology & Hematology of Central Illinois

Peoria, Illinois, 61602, United States

Location

Blessing Cancer Center

Quincy, Illinois, 62301, United States

Location

Central Indiana Cancer Centers - Indianapolis

Indianapolis, Indiana, 46227, United States

Location

Norton Healthcare - Louisville Oncology

Louisville, Kentucky, 40202, United States

Location

Maryland Oncology Hematology, PA

Columbia, Maryland, 21044, United States

Location

Alliance Hematology Oncology, PA - Carroll County Cancer Center

Westminster, Maryland, 21157, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Minnesota Onc/Hem, PA - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of MN/Division of Hematology, Oncology & Transplantation

Minneapolis, Minnesota, 55455, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64507, United States

Location

Arch Medical Group - Arch Medical Services, Inc.

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

New York Oncology Hematology, PC

Albany, New York, 12208, United States

Location

SUNY Upstate Medical Center

Syracuse, New York, 13210, United States

Location

Northwestern Carolina Oncology & Hematology

Hickory, North Carolina, 28602, United States

Location

Raleigh Hematology Oncology Associates

Raleigh, North Carolina, 27607, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Medical Oncology Associates

Kingston, Pennsylvania, 18704, United States

Location

University of Tennessee Medical Center, Knoxville

Knoxville, Tennessee, 37920, United States

Location

Sarah Cannon

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - Amarillo

Amarillo, Texas, 79106, United States

Location

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702-1449, United States

Location

Texas Oncology, PA - Bedford

Bedford, Texas, 76022, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230-2510, United States

Location

Texas Oncology, P.A. - Dallas

Dallas, Texas, 75246, United States

Location

Texas Oncology, P.A., Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology, PA - Fort Worth

Fort Worth, Texas, 76104, United States

Location

West Texas Cancer Center

Odessa, Texas, 79761, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology Cancer Care and Research Center

Waco, Texas, 76712, United States

Location

Texas Oncology, PA - Deke Slayton Cancer Center

Webster, Texas, 77598, United States

Location

Texas Oncology - Wichita Falls

Wichita Falls, Texas, 76310, United States

Location

Virginia Oncology Associates - Norfolk, VA

Norfolk, Virginia, 23502, United States

Location

Oncology & Hematology Associates of Southwest Virginia, Inc.

Salem, Virginia, 24153, United States

Location

Puget Sound Cancer Center

Seattle, Washington, 98133, United States

Location

Northwest Cancer Specialists - Vancouver Cancer Center

Vancouver, Washington, 98684, United States

Location

Yakima Regional Cancer Care Center - North Star Lodge Cancer Center

Yakima, Washington, 98902, United States

Location

Free University Medical Center

Amsterdam, NL 1081 HV, Netherlands

Location

Royal Marsden Hospital in Downs Road

Sutton, Surrey, United Kingdom

Location

Related Publications (2)

• Ettinger DS, Jotte R, Lorigan P, Gupta V, Garbo L, Alemany C, Conkling P, Spigel DR, Dudek AZ, Shah C, Salgia R, McNally R, Renschler MF, Oliver JW. Phase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer. J Clin Oncol. 2010 May 20;28(15):2598-603. doi: 10.1200/JCO.2009.26.7682. Epub 2010 Apr 12.

  PMID: 20385980 BACKGROUND

• Spigel DR, et al. Amrubicin (AMR) and cardiotoxicity in second-line treatment of small cell lung cancer (SCLC): A pooled analysis of left ventricular ejection fraction (LVEF) in two phase II trials. 2009 ASCO Annual Meeting, May 29-June 2, 2009, Chicago, IL. Abstract No.e19019. J Clin Oncol 2009;27(suppl)

  BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

amrubicin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Richard S Ungerleider, MD

  Theradex

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2006
• First Posted: September 12, 2006
• Study Start: November 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: March 1, 2009
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

GB (1); NL (1); US (44)